Device recall: Enterprise 1.5T, Model Number: 781145;
Class II FDA enforcement event 96728. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
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 NEDERLAND B.V. started this device recall on 24 Mar 2025. The firm address in the FDA record is in Best. FDA put the recall in Class II. FDA event 96728 has 14 product records. The first FDA enforcement report date is 21 May 2025. The record gives the status Ongoing.
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.
US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada,…
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
14 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1770-2025 | Enterprise 1.5T, Model Number: 781145; | 34 units (32 US, 2 OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1771-2025 | Intera 0.5T Standard, Model Number: 781101; | 14 units (All OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1772-2025 | Intera 1.0T Omni/Stellar, Model Number: 781102; | 37 units (3 US, 34 OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1773-2025 | Intera 1.0T Power/Pulsar, Model Number: 781103; | 26 units (All OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1774-2025 | Intera 1.5T, Model Numbers: 781195 and 781295; | 376 units (37 US, 339 OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1775-2025 | Intera 1.5T Explorer/Nova Dual, Model Number: 781108; | 12 units (2 US, 10 OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1776-2025 | Intera 1.5T Master/Nova, Model Number: 781106; | 103 units (37 US, 66 OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1777-2025 | Intera 1.5T Omni/Stellar, Model Number: 781104; | 26 units (7 US, 19 OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1778-2025 | Intera 1.5T Power/Pulsar, Model Number: 781105; | 121 units (51 US, 70 OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1779-2025 | Intera 1.5T R11, Model Number: 781170; | 23 units (10 US, 13 OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1780-2025 | Intera 3.0T Quasar Dual, Model Number: 781150; | 12 units (5 US, 7 OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1781-2025 | Intera CV, Model Number: 781107; | 6 units (4 US, 2 OUS) | Class II | Ongoing | 21 May 2025 |
| Z-1782-2025 | SmartPath to dStream for 1.5T, Model Number: 782146; | 3 units OUS | Class II | Ongoing | 21 May 2025 |
| Z-1783-2025 | SmartPath to dStream for 3.0T, Model Number: 782145; | 4 units OUS | Class II | Ongoing | 21 May 2025 |
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 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 14Median of the firm: 1
- Events of the firm on the register
- 59
Other events of the firm
Official channels
- FDA enforcement report Z-1770-2025The 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.
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Cite this page
Recall Register. FDA enforcement event 96728. https://recallregister.com/fda/ii/96728/. 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:
US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada,…
- What quantity of product is in FDA event 96728?
- The event has 14 product records. The first record gives this quantity:
34 units (32 US, 2 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.