DigitalDiagnost C50 1 — Class II medical device recall Z-1383-2023
Ongoing recall by Philips North America Llc, reported 2023-04-19, distributed nationwide. If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU),
| Recall number | Z-1383-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2023-03-09 |
| Classified | 2023-04-12 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BG, CH, CN, CO, CY, CZ, DE, EG, ES, FR, GR, HU, ID, IT, JO, KE, LK, LT, LV, MT, MX, NL, NZ, PH, PL, PT, RS, SA, SI, TH, VN, ZA |
| UPC / GTIN / UDI-DI | 00884838095199 |
| Serial numbers | 200001, 200002, 200005, 200006, 200007, 200009, 200010, 200011, 200012, 200013, 200014, 200015, 200017, 200018, 200019, 200022, 200023, 200024, 200026, 200027, 200028, 200029, 200030, 200031, 200032 and 268 more |
| Model numbers | 712204 |
Product
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Reason for recall
If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users
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-1383-2023. 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.