FDA Medical devices recall ·
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system recall
- Recall number
- Z-0719-2026
- Date
- (initiated October 2, 2025)
- Company / brand
- Philips Medical Systems Nederland B.V.
Veenpluis 4-6, Best, N/A, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 172 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Why was it 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. Expansion to add additional model.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 722234;
Distribution
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;
States: Alabama Arkansas Arizona California Colorado Florida Georgia Hawaii Illinois Indiana Kansas Kentucky Maryland Minnesota Missouri New Mexico New York Ohio Oklahoma Pennsylvania Rhode Island Texas Utah Virginia Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0719-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.