AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO a
Summary
The FDA issued a Class II for AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in c by Siemens Medical Solutions USA, Inc. Reason: Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire.
Details
Source
Device Recall
External ID
Z-2180-2024
Action Date
2024-07-03
Status
Ongoing
Category
device
Product 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
Lot/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
Quantity Affected: 50 units
Reason for Recall
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-31
Company
Malvern, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc have FDA actions?
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2180-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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