FDA Device recall Z-0512-2018
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging a…
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging a… by Philips Medical Systems Cleveland, citing during collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0512-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-15 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
Reason
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Identifiers
| code_info | Brightview Model 882480 Serial Numbers : 4000410 4000651 4000652 4000665 4000688 4000350 4000065 4000061 400…Brightview Model 882480 Serial Numbers : 4000410 4000651 4000652 4000665 4000688 4000350 4000065 4000061 4000180 4000224 4000321 4000298 4000552 4000280 4000378 4000336 4000559 4000229 4000262 4000681 4000009 4000184 4000554 4000516 4000303 4000576 4000190 4000305 4000411 4000669 4000614 4000324 4000612 4000566 4000627 4000218 4000123 4000287 4000070 4000166 4000202 4000102 4000276 4000091 4000301-1 4000455 4000033 4000364 4000008 4000497 4000498 4000699 4000012 4000213 4000413 4000472A 4000581 4000469 4000648 4000510 4000454 4000335 4000436 4000353 4000418 4000491 4000571 4000197 4000555 4000518 4000544 4000500 4000592 4000617 4000005 4000379 4000451 4000533 4000602 4000137 4000343 4000030 4000540 4000316 4000342 4000408 4000421 4000495 4000511 4000664 4000317 4000338 4000604 4000682 4000647 4000341 4000057-OLD 4000389 4000290 4000283 4000312 4000328 4000375 4000560 4000366 4000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0512-2018%22
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