Agency classClass IIOur severity:Severe FDA (Devices)·Z-0299-2019·Announced 2018-11-07

Siemens Ysio Radiographic Systems Recalled for Potential Tube Arm Drop

Siemens is recalling 142 Ysio radiographic systems because steel cables may rupture, causing the tube 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 tube 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 142 units of the Ysio radiographic system (model numbers 10281013 or 10281163) equipped with the Tube stand 3D V (model numbers 7042018 or 7042034). These systems are used for radiographic and tomographic exposures of the whole body. The affected units were distributed to 38 US states and the District of Columbia.

The recall is due to a defect in the steel cables inside the lifting column of the overhead tube. In rare cases of high clinical workload, these cables may rupture without triggering the safety lock. This failure could overload the safety rope, leading to mechanical fatigue and causing the arm to drop down unexpectedly during vertical movement or patient positioning.

Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. Siemens is the recalling firm and is responsible for addressing the defect.

The recalled product

Product: Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiographic Systems
Hazard: falling-object
mechanical-failure
Affected units: 142

Distribution

Distributed in 38 states:

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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