The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0298-2019·Announced 2018-11-07

Siemens AXIOM Multix MT Patient Table Recalled for Cable Failure Risk

Siemens is recalling 11 AXIOM Multix MT patient tables because steel cables may rupture, causing the arm to drop unexpectedly during patient positioning.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device that could cause the arm to drop unexpectedly, posing a significant risk of injury to patients or staff, which aligns with the 'Severe' criteria for significant injury reports or structural defects.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 11 units of the AXIOM Multix MT patient table (model numbers 8395415, 8395399, or 8395381). These tables are used with Siemens Multix PRO- and TOP Systems for radiographic exposures of the entire body. The affected units have serial numbers 1137, 1138, 1525, 1121, 1132, 1529, 1074, 1531, 1472, 1136, and 1119.

The recall is due to a potential mechanical defect where steel cables inside the lifting column may rupture in rare cases of high clinical workload. This failure could overload the safety rope, leading to mechanical fatigue and causing the arm to drop unexpectedly during vertical movement or patient positioning. The products were distributed to facilities in 38 US states and the District of Columbia.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this defect. The source text does not specify a specific action for consumers, as the product is a medical device used in clinical settings.

The recalled product

Product
AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.
Affected units
11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers 1137 1138 1525 1121 1132 1529 1074 1531 1472 1136 1119

Distribution

Part of a larger recall action

This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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