Reported Jul 4, 2018 · Terminated
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
Philips Medical Systems Nederlands
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems Nederlands · Veenpluis 4-6 · Best · N/A
Is this the product you have?
- OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
- Lot codes and dates
- As-Maintained System Equipment Number
429 of 429 codes
765963835176948504288265513124851632503408654987164869778696586340152010115418731021641029778387183958861131048571030521032198485086303103055103058103218104012104934104577105324504972504297104858529688527085527086527104527090527082529687527080527087529686527091527092527089527093529705527109527088527102527107527083527084529703529699529713
- As-Maintained System Equipment Number
- Amount recalled
- 477
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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