Nuclear gamma cameras — Class II medical device recall Z-1510-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-05-07. Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector h
| Recall number | Z-1510-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2014-03-10 |
| Classified | 2014-04-25 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2015-08-04 |
| Countries outside the US | AT, AU, BE, BR, CA, CN, DE, DK, EG, ES, FR, GB, HK, IE, IT, KR, LB, MY, NL, NO, PK, PT, RU, SE, SG, TH |
| Quantity | 1,043 cameras |
| Serial numbers | 0002032, 0007001M, 0008009B, 0011002B, 0101002C, 0102019V, 0103020V, 01069VM, 01070VM, 0111001V, 01295VM, 01296K, 01864VM, 03026VM, 0407V, 0682V, 0795V, 0822VP2, 0939VM, 100098-01N, 1006, 1008, 10252, 1027, 103 and 351 more |
Product
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
Reason for recall
Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.
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-1510-2014. 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.