Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-0719-2026

Z-0719-2026 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A

FDA device recall Z-0719-2026 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on October 2, 2025 and is designated Class II. 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-corro… The recall status is ongoing. Affected quantity: 172 units.

Recall Details

Product Type
Devices
Report Date
December 3, 2025
Initiation Date
October 2, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
172 units

Product Description

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

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.

Distribution Pattern

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;

Code Information

Model Number: 722234;

Other recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  • Z-2932-2026 Class II — Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, (July 16, 2026)
  • Z-2931-2026 Class II — Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, (July 16, 2026)
  • Z-2928-2026 Class II — Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 7 (June 29, 2026)
  • Z-2893-2026 Class II — Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interve (June 17, 2026)
  • Z-2892-2026 Class II — Philips Azurion under the following System Descriptions and corresponding model (June 17, 2026)
  • Z-2891-2026 Class II — Philips Allura under the following System Descriptions and corresponding model n (June 17, 2026)
  • Z-2411-2026 Class II — Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 (May 18, 2026)
  • Z-2412-2026 Class II — Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura (May 18, 2026)
  • Z-2259-2026 Class II — Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003 (April 30, 2026)
  • Z-2258-2026 Class II — Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, (April 30, 2026)

FDA data resources