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.
Reason for recall: 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. Distribution: Domestic distribution nationwide. Foreign distribution worldwide. Quantity: 359 US; 328 OUS Lot/code info: 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 4000472A 4000544 4000555 4000592 4000581 4000571 4000617 4000648 4000042 4000005 4000379 4000451 4000533 4000602 4000032 4000029 4000039 4000056 4000051 4000068 4000067 4000045 4000071 4000088 4000006 4000129 4000158 4000003 4000290 4000370 4000283 4000366 4000372 4000328 4000375 4000346 4000336 4000122 4000422 4000417 4000223 4000423 4000301 4000057 4000151 4000197_1 4000487 4000466 4000381 4000536 4000549 4000557 4000550 4000031 4000560 4000567 4000483 4000620 4000607 4000601 4000683 4000343 4000540
40007050005, 40007060008, 40007060007
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.