CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report

3D V recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling 3D V, distributed nationwide in the US. The recall was initiated on 29 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes7042042 : S/N 1002 to 1787 7042059: S/N 1002 to 1921

Quantity recalled667

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2838-2018
FDA event ID: 80735
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 29 Jun 2018
FDA classified: 17 Aug 2018
Reported: 29 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

29 Jun 2018	Recall initiated by company
17 Aug 2018	Classified by FDA	+49 days
29 Aug 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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 ceiling stand can be used within a stationary diagnostic X-ray system as well.

Where it was distributed

US Nationwide Distribution to accounts in IL, FL, and NY.

Nationwide Florida Illinois New York

Questions about this recall

Is 3D V recalled?

Yes. Siemens Medical Solutions USA recalled 3D V on 29 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-2838-2018.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide Distribution to accounts in IL, FL, and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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