Device recall: CombiDiagnost R90 Software Version R1.0 and R1.1
Class II FDA enforcement event 88393. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
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 Gmbh, DMC started this device recall on 22 Jul 2020. The firm address in the FDA record is in Hamburg. FDA put the recall in Class II. FDA event 88393 has 1 product record. The first FDA enforcement report date is 8 Sep 2021. 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
Recalling firm
Philips Medical Systems Gmbh, DMC, Hamburg, N/A, Germany.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: FDA Mandated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2357-2021 | CombiDiagnost R90 Software Version R1.0 and R1.1 | 322 systems; 66 in US | Class II | Ongoing | 8 Sep 2021 |
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 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Dec 2019 | CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, genera | Device | Class II | 2 |
| 7 Nov 2018 | Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System | Device | Class II | 1 |
| 19 Sep 2018 | Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 7120 | Device | Class II | 1 |
| 27 Jun 2018 | DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 | Device | Class II | 28 |
Official channels
- FDA enforcement report Z-2357-2021The 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 88393. https://recallregister.com/fda/ii/88393/. 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
- What quantity of product is in FDA event 88393?
- The FDA record gives this quantity:
322 systems; 66 in US
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many device recalls of 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.