FDAClass IIAugust 29, 2018

3D V, model. no. 7042042 7042059 3070021 Product Usage recall

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…

Why was 3D V, model. no. 7042042 7042059 3070021 Product Usage recalled?

In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break without triggering the safety lock and this could lead to overloading the safety rope which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down during patient positioning. Patients and users may be seriously injured.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

7042042 : S/N 1002 to 1787 7042059: S/N 1002 to 1921

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…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
667
Distribution
US Nationwide Distribution to accounts in IL, FL, and NY.
Recall date
August 29, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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