—#205331

Product

Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K200917
Affected lot / code info: (1) System Code: 722079; (1) UDI/DI: 00884838085268; (1) Serial Number: 1005, 866, 1361, 952, 1241, 1169, 756, 703351, 1135, 1122, 824, 748, 630, 638, 703385, 812, 703346, 1303, 1313, 893, 768, 929, 703638, 1357, 703810, 934, 1202, 703461, 703706, 1172, 703959, 703845, 703705; (2) System Code: 722224; (2) UDI/DI: 00884838099258; (2) Serial Number: 539, 395, 278, 134, 730, 252, 370, 36, 572, 645, 272, 495, 781, 62, 1388, 352, 1655, 690, 555, 895, 2165, 861, 60, 20, 648, 2231, 1778, 1431, 778, 477, 917, 1718, 388, 2042, 150, 764, 2036, 1421, 157, 879, 212, 144, 1463, 347, 575, 2187, 355, 2576, 1332, 424, 387, 863, 211, 474, 712, 549, 2309, 799, 2283, 639, 1700, 2071, 537, 1589, 2208, 2057, 771, 772, 1216, 1667;

Why it was recalled

Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The recalling firm issued an URGENT: MEDICAL DEVICE CORRECTION notification dated 12/08/2023 by certified mail to consignees. Consignees with affected devices are asked to utilize the provided workaround instructions. Additionally, consignees are asked to make all users aware of this recall notification and keep a copy of this notification with system documentation. Getinge Field Service Engineers will be dispatched to the field to install software updates to affected devices. Consignees with any questions can contact the recalling firm by phone at 1-800-722-9377. Consignees are asked to return the provided response form to the recalling firm at ITG_Recalls@philips.com.

Recalling firm

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

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.

Timeline

Recall initiated: 2023-12-08
Posted by FDA: 2024-01-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205331. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.