PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
- Reason / hazard
- 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. Expansion to add additional model.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Domestic: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MD, MN, MO, NM, NY, OH, OK, PA, RI, TX, UT, VA, WA, WI, WV, WY; International: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Netherlands, Norway, Philippines, Poland, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Vietnam;
- Recall initiated
- 2025-10-02
- Code info
- Model Number: 722234;
- Product quantity
- 172 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Best
- State
- N/A
- Country
- Netherlands
- Event id
- 97719
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