FDA Device recall Z-0677-2024
BrightView, Gamma Camera System, Product Code 882480
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of BrightView, Gamma Camera System, Product Code 882480 by Philips North America, citing while using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0677-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-30 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
BrightView, Gamma Camera System, Product Code 882480.
Reason
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
Identifiers
| code_info | No UDI Serial numbers 4000002 4000262 4000681 4000218 4000413 4000312 4000389 4000678 4000484 4000288 4000393 4000393…No UDI Serial numbers 4000002 4000262 4000681 4000218 4000413 4000312 4000389 4000678 4000484 4000288 4000393 4000393 4000494 4000354 4000699 4000515 4000679 4000479 4000689 4000082 4000373 4000471 4000545 4000331 4000038 4000002 4000060 4000161 4000164 4000360 4000175 4000244 4000186 4000242 4000235 4000255 4000247 4000320 4000347 4000367 4000402 4000430 4000473 4000591 4000537 4000505 4000529 4000524 4000562 4000582 4000606 4000583 4000584 4000662 4000674 4000696 4000282 4000449 7135_11 4000410 4000651 4000652 4000665 4000688 4000350 4000044 4000061 4000081 4000065 4000002.75 4000180 4000224 4000321 4000229 4000280 4000378 4000559 4000552 4000298 4000009 4000190 4000184 4000305 4000303 4000324 4000411 4000516 4000554 4000566 4000576 4000614 4000612 4000627 4000669 4000033 4000070 4000091 4000123 4000102 4000008 4000202 4000166 4000276 4000287 4000364 4000455 4000498 4000497 4000012 4000213 4000197 4000353 4000335 4000418 4000510 4000436 4000454 4000469 4000500 4000491 4000518 400047 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0677-2024%22
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