Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Date of Enforcement Report: 5/24/2024
Class II
PRODUCT
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Recall Number:
Z-1895-2024
REASON:
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
RECALLING FIRM/MANUFACTURER:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
VOLUME OF PRODUCT IN COMMERCE:
1 unit (US)
DISTRIBUTION:
Domestic: OK International: India, Spain, U.A.E.
