Nuclear Gamma Cameras — Class II medical device recall Z-1598-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-05-20, distributed nationwide. During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree posit
| Recall number | Z-1598-2015 |
|---|---|
| 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 | 2015-03-13 |
| Classified | 2015-05-12 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2018-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CN, CR, DE, DK, EG, ES, FR, GB, IE, IT, JP, KR, LB, MY, NL, NO, PK, PT, RU, SE, TH |
| Quantity | 918 units |
| Serial numbers | 0007001M, 0008009B, 0011002B, 00559VM, 00634V, 00657VA, 00970VA, 0102019V, 0103020V, 01069VM, 01070VM, 0111001V, 01190VM, 01295VM, 01296K, 01697VM, 01864VM, 01894VM, 03026VM, 0371V, 0407V, 0682V, 0795V, 0822VP2, 0939VM and 270 more |
| Model numbers | 882030, 88297, 890122 |
Product
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
Reason for recall
During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.
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-1598-2015. 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.