Reported Sep 11, 2024 · Ongoing
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model…
Philips Medical Systems Nederland B.v.
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 NEDERLAND B.V. · Veenpluis 4-6 · Best · N/A
Is this the product you have?
- Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
- Lot codes and dates
- UDI-DI(01)00884838085268 (01)00884838099258
- Serial Numbers88
2612771257277013163067703615292926751391597033351018703497272711702957266116076621561615163716511657192564337063733127931405588224123252326232712787407478518521040
49 39447227811648661063145911912131985813814409312029957034192972199410822390138895120112341102865155429522549128324482220823824125825116269011571290629182996703486203010241346134710038503382636194011321456445802981
41140 of 140 codes
7534345839682177335114328317035847387033508473271223954192104622801343011064461136170342025244147927644031931433126521721215262311136313641365315392542210371739826191787187317811929243510052782229224622472248137613771514
4026871084183821952196945237012669583152483484703408395845469217214307033687035624174324395166306457701309131013711614193427651395566170672319827872672687887894783461431124412451311117831285611503063909735264713151484
36104 of 104 codes
731108314441517290329071611142317730397033072791252151983270345021311091703528137413751939100411022288467468539242112840010061098730364703345127613091493103215272900726128896396555213811382115683925414034401382246218424361959613
90148371516621781663253122812207033057033601410
199512701274285926192620122125042198
- Amount recalled
- 927 systems
Where it was sold
- Nationwide
Why it was recalled
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel.
This product could cause temporary or reversible health problems — stop using it.
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