Siemens 3D V Ceiling Stand Recalled for Potential Rope Failure
Siemens is recalling 3D V ceiling stands because the primary load-bearing rope could break, causing the arm to drop and potentially seriously injuring patients or users.
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 source text explicitly states that patients and users 'may be seriously injured' due to the mechanical failure of the device, which aligns with the rubric criterion for 'significant injury' reports or risks associated with a Class II recall involving serious harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 667 units of the 3D V ceiling stand (model numbers 7042042 and 7042059). These devices are used to hold X-ray tubes and detectors on a ceiling rail system in diagnostic imaging settings. The affected units were distributed nationwide to accounts in Illinois, Florida, and New York.
The recall is due to a risk that the primary load-bearing rope could break in rare cases of insufficient maintenance or high clinical workload. If this occurs, the safety lock may not trigger, placing continuous load on the secondary safety rope. This can lead to mechanical fatigue and cause the arm to drop during patient positioning, which may result in serious injury to patients and users.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 667
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)
- 7042042 : S/N 1002 to 1787 7042059: S/N 1002 to 1921
Distribution
Part of a larger recall action
This product is one of 2 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.
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