FDA Device recall Z-2301-2018

OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025

FDA Device
Class II
terminated
Published 2018-07-04

On 2018-07-04 the FDA classified a Class II recall of OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025 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-2301-2018
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 Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025

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: 76596 38351 76948 50428 82655 13124 85163 250340 86549 87164 86977 86… As-Maintained System Equipment Number: 76596 38351 76948 50428 82655 13124 85163 250340 86549 87164 86977 86965 86340 1520 101154 1873 102164 102977 83871 83958 86113 104857 103052 103219 84850 86303 103055 103058 103218 104012 104934 104577 105324 504972 504297 104858 529688 527085 527086 527104 527090 527082 529687 527080 527087 529686 527091 527092 527089 527093 529705 527109 527088 527102 527107 527083 527084 529703 529699 529713 529706 529712 529690 529710 529709 529708 529707 14629273 15893969 35015270 35014092 35127787 34997249 15849132 15857294 158554 15841822 15858211 16231503 15831844 16409964 16802355 18055578 18560502 15857902 15858098 303148 15854028 17492237 17541021 31456486 17758213 17941166 19392346 19579758 19782801 18809817 19257910 31103760 19782331 19935548 30396410 32054303 30194039 30873909 37103066 34090526 31596158 10135906 10166050 10006064

code_info

As-Maintained System Equipment Number: 76596 38351 76948 50428 82655 13124 85163 250340 86549 87164 86977 86…

As-Maintained System Equipment Number: 76596 38351 76948 50428 82655 13124 85163 250340 86549 87164 86977 86965 86340 1520 101154 1873 102164 102977 83871 83958 86113 104857 103052 103219 84850 86303 103055 103058 103218 104012 104934 104577 105324 504972 504297 104858 529688 527085 527086 527104 527090 527082 529687 527080 527087 529686 527091 527092 527089 527093 529705 527109 527088 527102 527107 527083 527084 529703 529699 529713 529706 529712 529690 529710 529709 529708 529707 14629273 15893969 35015270 35014092 35127787 34997249 15849132 15857294 158554 15841822 15858211 16231503 15831844 16409964 16802355 18055578 18560502 15857902 15858098 303148 15854028 17492237 17541021 31456486 17758213 17941166 19392346 19579758 19782801 18809817 19257910 31103760 19782331 19935548 30396410 32054303 30194039 30873909 37103066 34090526 31596158 10135906 10166050 10006064

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-2301-2018%22

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