Siemens 3D TOP Ceiling Stand Recalled for Potential Rope Failure
Siemens Medical Solutions is recalling 699 3D TOP Ceiling Stands because a load-bearing rope could break, causing the arm to drop and potentially seriously injure 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, which aligns with the rubric criteria for a score of 4 (Severe) involving significant injury reports or risks.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 699 units of the 3D TOP Ceiling Stand (model numbers 3070039, 3074486, 3070013, and 3070021). These devices are used to hold X-ray tubes and detectors on a ceiling rail system in diagnostic imaging settings. The recall covers units distributed nationwide to accounts in Illinois, Florida, and New York.
The recall is due to a mechanical defect where 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 a secondary safety rope not designed for such conditions. This can lead to mechanical fatigue and cause the arm to drop during patient positioning, posing a risk of serious injury to patients and users.
Healthcare facilities should stop using the affected ceiling stands immediately. Siemens Medical Solutions is the recalling firm and is responsible for managing the recall. Affected serial number ranges are: 3070039 (S/N 2271 to 2793), 3074486 (S/N 1812 to 3036), 3070013 (S/N 3967 to 5042), and 3070021 (S/N 3852 to 4719).
The recalled product
- Product
- 3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 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…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 699
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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