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FDA (Device enforcement)Recalled 2017-12-15closedclass ii

Philips Medical Systems (Cleveland) Inc: BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad

Is my product affected?

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 studie

  • UPC 40007060008
  • UPC 40007050005
  • UPC 40007060007
  • UPC 40007030003
  • UPC 40007060006

Check against the official notice below — it lists the full affected range.

What happened

Philips Medical Systems is recalling BrightView Model 882480 gamma cameras used for nuclear imaging due to a hazard during collimator exchange procedures. When exchanging the collimator, misalignment between the collimator cart and detectors may cause the exchange to fail, resulting in the collimator dropping to the floor beside the cart. The collimator may fall completely to the floor or remain partially supported by the cart. The recall affects 1,387 units distributed nationwide and worldwide, identified by specific serial numbers beginning with "4000."

The product recall record does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide Distribution - US Nationwide Quantity: 1387 in total Lot/code info: 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 4000417 4000051 4000372 4000151 4000422 4000195 4000088 4000381 4000071 4000003 4000549 4000487 4000056 4000006 4000466 4000550 4000346 4000683 4000483 4000301 4000158 4000223 4000129 4000045 4000057 4000557 4000567 4000370 4000536 4000029 4000607 4000067 4000068 4000032 4000423 4000039 4000031 4000620 4000678 4000601 4000122 4000286 4000294 4000395 4000672 4000348 4000613 4000655 4000390 4000419 4000462 4000463 4000464 4000638 4000296 4000199 4000096 4000281 4000288 10422 199 281 288 422 4000002 4000268 4000382 4000692 4000693 4000337 4000595 4000447 4000273 4000169 4000442 4000412 4000488 4000297 400022

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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