CLASS II ONGOING Device recall · Reported 21 Feb 2024 · FDA Enforcement Report
CombiDiagnost R90 1 (709031) recalled by Philips Medical Systems
Philips Medical Systems is recalling CombiDiagnost R90 1 (709031), distributed nationwide in the US. The recall was initiated on 11 Feb 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1088-2024
- FDA event ID
- 93819
- Recalling firm
- Philips Medical Systems, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Feb 2022
- FDA classified
- 14 Feb 2024
- Reported
- 21 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Feb 2022 | Recall initiated by company | |
| 14 Feb 2024 | Classified by FDA | +733 days |
| 21 Feb 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
Product as listed by the FDA
CombiDiagnost R90 1.1 (709031)
Where it was distributed
US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.
Nationwide CaliforniaFloridaGeorgiaIllinoisIndianaKansasMarylandMaineMichiganMinnesotaNorth CarolinaNew JerseyNew YorkTexasVirginiaWashington
Questions about this recall
Is CombiDiagnost R90 1 (709031) recalled?
Yes. Philips Medical Systems recalled CombiDiagnost R90 1 (709031) on 11 Feb 2022. The recall is Class II and its status is Ongoing. Recall number Z-1088-2024.
Why was it recalled?
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
Which lots are affected?
Model: R90 1.1 (709031); UDI DI: 00884838101456; Software version 1.1.1 or higher; Serial Numbers: 10001004, 10001005, 10001006, 10001008, 10001009, 10001010, 10001011, 10001012, 10001013, 10001018, 10001020, 10001022, 10001024, 10001026, 10001027, 10001028, 10001029, 10001030, 10001031, 10001032, 10001035, 10001036, 10001043, 10001044, 10001045, 10001046, 10001047, 10001048, 10001049, 10001050, 10001051, 10001052, 10001053, 10001054, 10001055, 10001056, 10001057, 10001058, 10001059, 10001060, 10001061, 10001062, 10001063, 10001064, 10001065, 10001066, 10001067, 10001068, 10001069, 10001070, 10001071, 10001072, 10001073, 10001074, 10001075, 10001076, 10001077, 10001078, 10001079, 10001080, 10001081, 10001083, 10001084, 10001085, 10001086, 10001087, 10001088, 10001089, 10001090, 10001091, 10001092, 10001093, 10001094, 10001095, 10001096, 10001097, 10001098, 10001099, 10001100, 10001101, 10001102, 10001103, 10001104, 10001105, 10001106, 10001107, 10001108, 10001109, 10001110, 10001111, 10001112, 10001113, 10001114, 10001115, 10001116, 10001117, 10001118, 10001119, 10001120, 10001121, 10001122, 10001123, 10001124, 10001125, 10001126, 10001127, 10001128, 10001129, 10001130, 10001131, 10001132, 10001133, 10001134, 10001135, 10001136, 10001137, 10001138, 10001139, 10001140, 10001141, 10001142, 10001143, 10001144, 10001145, 10001147, 10001148, 10001149, 10001150, 10001152, 10001201;
Where was it sold?
US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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