FDA Enforcement
Class II
Ongoing
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399
Recall: Z-2180-2024
·
Reported July 3, 2024
Enforcement
- Recall Number
- Z-2180-2024
- Event ID
- 94777
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- July 3, 2024
- Initiation Date
- May 31, 2024
- Classification Date
- June 25, 2024
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418, United States
Description
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399
Reason
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Code Info
UDI-DI: N/A Serial Numbers: 1003 1032 1039 1060 1065 1071 1076 1082 1083 1085 1089 1092 1104 1170 1174 1181 1183 1194 1304 1305 1309 1310 1315 1318 1323 1325 1331 1348 1359 1382 1395 1398 1423 1443 1444 1447 1449 1452 1453 1468 1498 1500 1508 1509 1512 1513 1515 1516 1525 1531
Distribution
US Nationwide distribution.
Quantity
50 units