Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems

FDA device recall Z-2485-2023 · posted 2023-08-30 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

Loss of availability of the wireless foot switch during procedures.

Action taken

Customers were sent an URGENT Medical Device Correction letter dated 6/23/2023 via USPS Certified Mail. Customers are instructed to ensure that the wired footswitch is always connected to the system in case the wireless foot switch becomes unavailable. Customers are instructed to download a copy of the addendum to the IFU for the wireless foot switch and the Quick Reference Card at Http://philips.com/doc_library, and distribute these materials to those who use the system and retain a copy with the system's IFU. These documents are to be placed in an area where they are likely to be seen/viewed with system documentation. Customers are to return the attached response form to Philips no later than 30 days from receipt of the notification to IGT_Recalls@philips.com. Philips will contact customers to schedule a Field Service Engineer visit to confirm that the wired foot switch is connected to affected systems, perform a check of the charger, and provide customers with a hardcopy of the addendum. Customers with questions can contact Philips Technical Support Line at 1-800-722-9377.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OWB

Quantity affected

1865 units

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Chile, China, Croatia, Czech Republic, Denmark, Egypt, Fiji, Finland,

Date initiated

2023-06-30

Date posted

2023-08-30

Location

Best, Netherlands

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