Nuclear gamma cameras — Class II medical device recall Z-1607-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-05-20, distributed nationwide. The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet w
| Recall number | Z-1607-2015 |
|---|---|
| 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 | 2015-03-11 |
| Classified | 2015-05-13 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2018-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CN, CR, DE, EG, ES, FR, GB, HK, IE, IT, JP, KR, LB, NL, NO, PK, PT, RU, SG, TH |
| Quantity | 975 units |
| Serial numbers | 0007001M, 0008009B, 0011002B, 0101002C, 0102019V, 0103020V, 01069VM, 01070VM, 0111001V, 01295VM, 01296K, 01609K, 01864VM, 03026VM, 0939VM, 100098-01N, 1006, 1008, 10252, 1027, 10588, 1062701, 10630, 1092, 1097 and 293 more |
| Model numbers | 882030, 882040, 88297 |
Product
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended 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
The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.
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-1607-2015. 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.