Device recall: Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System
Class II FDA enforcement event 82038. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Philips Medical Systems Nederlands started this device recall on 21 Dec 2018. The firm address in the FDA record is in Best. FDA put the recall in Class II. FDA event 82038 has 64 product records. The first FDA enforcement report date is 6 Mar 2019. The record gives the status Terminated, with the termination date 19 Nov 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
U.S. Nationwide distribution.
Recalling firm
Philips Medical Systems Nederlands, Best, Netherlands.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
64 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0869-2019 | Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0870-2019 | Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0871-2019 | Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0872-2019 | Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0873-2019 | Multiva 1.5T 16 R5, Model Number 781078. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0874-2019 | Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0875-2019 | Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0876-2019 | Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0877-2019 | Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0878-2019 | Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0879-2019 | Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0880-2019 | Intera 1.5T CV, Model Number 781107. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0881-2019 | Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0882-2019 | Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0883-2019 | Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0884-2019 | Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0885-2019 | Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0886-2019 | Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0887-2019 | Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0888-2019 | Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0889-2019 | Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0890-2019 | Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0891-2019 | Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0892-2019 | Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0893-2019 | Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0894-2019 | Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0895-2019 | Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0896-2019 | Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0897-2019 | Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0898-2019 | Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0899-2019 | Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0900-2019 | SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0901-2019 | Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0902-2019 | Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0903-2019 | SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0904-2019 | Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0905-2019 | Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0906-2019 | Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0907-2019 | Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0908-2019 | Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0909-2019 | Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0910-2019 | Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0911-2019 | Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0912-2019 | Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0913-2019 | Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0914-2019 | Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0915-2019 | Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0916-2019 | Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0917-2019 | Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0918-2019 | Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0919-2019 | Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0920-2019 | Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0921-2019 | Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0922-2019 | Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0923-2019 | Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0924-2019 | MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0925-2019 | MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0926-2019 | MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0927-2019 | Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
| Z-0928-2019 | Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System | 11226 total | Class II | Terminated | 6 Mar 2019 |
The table shows 60 of 64 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 64Median of the firm: 2
- Events of the firm on the register
- 8
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Mar 2019 | Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are i | Device | Class II | 1 |
| 19 Feb 2019 | Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura | Device | Class II | 2 |
| 3 Dec 2018 | Ingenia Elition S, Ingenia Elition X | Device | Class II | 1 |
| 30 Nov 2018 | Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 | Device | Class II | 1 |
| 1 May 2018 | OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028 | Device | Class II | 2 |
| 26 Mar 2018 | MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography a | Device | Class II | 7 |
| 23 Jun 2016 | Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0869-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 82038. https://recallregister.com/fda/ii/82038/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
U.S. Nationwide distribution.
- What quantity of product is in FDA event 82038?
- The event has 64 product records. The first record gives this quantity:
11226 total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.