FDA Device recall Z-2300-2018

OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028

FDA Device
Class II
terminated
Published 2018-07-04

On 2018-07-04 the FDA classified a Class II recall of OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028 by Philips Medical Systems Nederlands, citing the fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2300-2018
Classification	Class II
Status	terminated
Initiated	2018-05-01
Published	2018-07-04
Last updated	2026-09-13 11:54 UTC
Company	Philips Medical Systems Nederlands
Distribution	US

Product

OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028

Reason

The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander.

Identifiers

code_info	As-Maintained System Equipment Number: 506241 500046 521648 522220 520020 533314 533471 533530 535257 535118… As-Maintained System Equipment Number: 506241 500046 521648 522220 520020 533314 533471 533530 535257 535118 535924 540860 539106 547017 547142 547348 550258 553235 556585 558404 553676 41446090 42036161 42383151 43180366 43680651 43721258 41444692 41445222 44650754 41445407 533112 541490 41955077 529685 529691 529684 529698 531893 529697 535941 529696 539264 546436 545873 539037 546528 546466 546455 545730 545598 539038 552988 551489 41455862 41444624 42065190 16846483 32253458 34036766 34179085 34968065 38562442 35122350 35127482 35016455 35145439 35112843 37601105 36664230 39524825 41681475 41827402 16724453 17005034 30533360 31497860 32026120 32205530 31595070 33426990 34135240 34819721 34819433 38632412 49595524 39740578 31605917 32310045 32008570 31954213 32749341 33426349 32865331 33827811 33827815 34087855 34087725 34079339 34793296 35569101 37097710 38745116 42

code_info

As-Maintained System Equipment Number: 506241 500046 521648 522220 520020 533314 533471 533530 535257 535118…

As-Maintained System Equipment Number: 506241 500046 521648 522220 520020 533314 533471 533530 535257 535118 535924 540860 539106 547017 547142 547348 550258 553235 556585 558404 553676 41446090 42036161 42383151 43180366 43680651 43721258 41444692 41445222 44650754 41445407 533112 541490 41955077 529685 529691 529684 529698 531893 529697 535941 529696 539264 546436 545873 539037 546528 546466 546455 545730 545598 539038 552988 551489 41455862 41444624 42065190 16846483 32253458 34036766 34179085 34968065 38562442 35122350 35127482 35016455 35145439 35112843 37601105 36664230 39524825 41681475 41827402 16724453 17005034 30533360 31497860 32026120 32205530 31595070 33426990 34135240 34819721 34819433 38632412 49595524 39740578 31605917 32310045 32008570 31954213 32749341 33426349 32865331 33827811 33827815 34087855 34087725 34079339 34793296 35569101 37097710 38745116 42

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-2300-2018%22

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