Spectral CT 7500 Computed Tomography X-Ray System — Class II medical device recall Z-1584-2023
Ongoing recall by Philips North America Llc, reported 2023-05-24, distributed nationwide. Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operat
| Recall number | Z-1584-2023 |
|---|---|
| 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 | 2023-03-17 |
| Classified | 2023-05-12 |
| Reported by FDA | 2023-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CH, CN, CZ, DE, DK, ES, FR, GB, IL, JP, KR, MY, NL, NO, PA, TH |
| Quantity | 92 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884838101111 |
| Serial numbers | 10014, 10015, 10016, 10017, 10018, 10019, 10020, 10021, 10022, 10023, 10024, 10025, 10027, 10031, 10032, 10033, 10034, 10035, 10036, 10038, 10039, 10040, 10041, 10042, 10043 and 67 more |
| Model numbers | 728333 |
Product
Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Reason for recall
Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.
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-1584-2023. 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.