CombiDiagnost R90 1 — Class II medical device recall Z-1088-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS, reported 2024-02-21, distributed nationwide. While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will a
| Recall number | Z-1088-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS, Cambridge, MA, United States |
| Recall initiated | 2022-02-11 |
| Classified | 2024-02-14 |
| Reported by FDA | 2024-02-21 |
| Distributed | Nationwide (US) |
| Quantity | 130 units |
| UPC / GTIN / UDI-DI | 00884838101456 |
| 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 and 105 more |
| Model numbers | 1.1, R90 |
Product
CombiDiagnost R90 1.1 (709031)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1088-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.