FDA Device recall Z-1510-2014
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143
- FDA Device
- Class II
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class II recall of Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143 by Philips Medical Systems Cleveland, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1510-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-10 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
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
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.
Identifiers
| code_info | ADAC Vertex Plus & ADAC Solus System Code: 88297, Serial #'s: 11, 1006, 1008, 1027, 1092, 1097, 2035, 2038, 2047, 3059,…ADAC Vertex Plus & ADAC Solus System Code: 88297, Serial #'s: 11, 1006, 1008, 1027, 1092, 1097, 2035, 2038, 2047, 3059, 3060, 3064, 4007, 4078, 6052, 6261, 8002, 10252, 10630, 11090, 85247, 513519, 513520, 940384, 9205345, 9408136, 9503084, 9506016, 9511123, 9512009, 9512018, 9601012, 9601015, 9601016, 9601024, 9601036, 9602161, 9602254, 9603336, 9604016, 9604021, 9605024, 9605026, 9605037, 9606211, 9607015, 9607024, 9608031, 9608046, 9608049, 9608052, 9609063, 9609081, 9610058, 9611035, 9611077, 9611082, 9612072, 9702095, 9702150, 9703154, 9703165, 9704044, 9704178, 9704183, 9705004, 9705186, 9706005, 9706182, 9706189, 9707002, 9707047, 9707050, 9707054, 9708062, 9708065, 9708076, 9708078, 9708084, 9708088, 9708227, 9709022, 9709061, 9710121, 9710127, 9710244, 9711025, 9711034, 9711036, 9711074, 9711271, 9711291, 9801047, 9801227, 9801232, 9801297, 9802050, 9802255, 9802260, 9802300, 9802306, 9802397, 9803003, 9803014, 9803067, 9803083, 9803269, 9803272, 9803288, 9803290, 9803293, 980 |
|---|
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-1510-2014%22
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