FDA Device recall Z-1598-2015
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
- FDA Device
- Class II
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH by Philips Medical Systems Cleveland, citing 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 chi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1598-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-13 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
Reason
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.
Identifiers
| code_info | Vertex Classic; Model #: 890122; Serial #s: 9404100, 9601238, 9609084, 0407V, 0682V, 0795V, 0822VP2, 103, 20, 500, 540…Vertex Classic; Model #: 890122; Serial #s: 9404100, 9601238, 9609084, 0407V, 0682V, 0795V, 0822VP2, 103, 20, 500, 5405V, 64, 9308007, 9309020, 9310032, 93-10660-1292, 9401059, 9401061, 9403076, 9403083, 9404106, 9407122, 9409148, 9410002, 9411006, 9411007, 9411016, 9501049, 9501210, 9502067, 9502086, 9503003, 9503079, 9503109, 9504019, 9505021, 9505124, 9506140, 9508169, 9508171, 9508184, 9508193, 9509198, 9509206, 9510222, 9510226, 9601146, 9602249, 9608042, 9901004, B0106154, B02120033, M@10229AMT, M@207JD, M@4404V, M@4431V, M@4432V, M@4480V, M@4623V, M@4630V, M@4639V, M@4686V, M@4692V, M@4858V, M@4893V, M@4959V, M@5032V, M@5033V, M@5038V, M@5105V, M@5145V, M@5158V, M@5189V, M@5280V, M@5289V, M@5338V, M@5360V, M@5373V, M@5398V, M@5407V, M@5412V, M@5431V, M@5439V, M@5467V, M@5476V, M@5497V, M@5498V, M@5515V, M@5526V, M@5590V, M@5617V, M@5627V, M@5661V, M@5662V, M@5663V, M@5665V, M@5681V, M@5688V, M@5689V, M@5751V, M@5752V, M@5782V, M@5811V, M@5835V, M@5869V, M@5900V, M@5913V, M@5915 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1598-2015%22
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