Reported Jul 4, 2018 · Terminated
OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
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-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
- Lot codes and dates
- As-Maintained System Equipment Number
466 of 466 codes
5062415000465216485222205200205333145334715335305352575351185359245408605391065470175471425473485502585532355565855584045536764144609042036161423831514318036643680651437212584144469241445222446507544144540753311254149041955077529685529691529684529698531893529697535941529696539264546436545873539037546528546466546455545730545598539038552988551489414558624144462442065190168464833225345834036766
- As-Maintained System Equipment Number
- Amount recalled
- 508
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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