CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system recalled
Philips Medical Systems Nederl is recalling Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, distributed in 28 states. The recall was initiated on 2 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0719-2026
- FDA event ID
- 97719
- Recalling firm
- Philips Medical Systems Nederl, Best, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Oct 2025
- FDA classified
- 26 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 2 Oct 2025 | Recall initiated by company | |
| 26 Nov 2025 | Classified by FDA | +55 days |
| 3 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Where it was distributed
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;
AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIllinoisIndianaKansasKentuckyMarylandMinnesotaMissouriNew MexicoNew YorkOhioOklahomaPennsylvania
Questions about this recall
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.
Which lots are affected?
Model Number: 722234;
Where was it sold?
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;
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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