Recalls / —

—#202568

Product

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

FDA product code

OWB — Interventional Fluoroscopic X-Ray System

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K161563, K200917

Affected lot / code info

Model No.: 722001, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722023, 722025, 722026, 722027, 722028, 722029, 722033, 722035, 722038, 722039, 722058, 722059, 722064, 722065, 722066, 722067, 722068, 722078, 722079; No UDI-DI; Lot No. 459800772231, 459800772233, 459800772261, 459800772263, 459800415531,459800415532, 459800415533, 459800415534, 459800415535, 459800415571, 459800415572, 459800415573, 459800415574, 459800415575.

Why it was recalled

Loss of availability of the wireless foot switch during procedures.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern

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, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kosovo, Latvia, Lebanon, Libya, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, and Yemen.

Timeline

Recall initiated

2023-06-30

Posted by FDA

2023-08-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202568. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.