Z-2838-2018Class II

3D V, model. no. 7042042 7042059 3070021

Name: Z-2838-2018 3D V, model. no. 7042042 7042059 3070021
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-06-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-06-29 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2018-06-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2838-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-29
Posted: 2018-08-17
Terminated: 2019-10-04
Recalling firm: Siemens Medical Solutions USA, Inc.
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 ceiling stand can be used within a stationary diagnostic X-ray system as well.
Product code: IYB Tube Mount, X-Ray, Diagnostic
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 6/29/18, the firm emailed its four affected original equipment manufacturers (OEMs), alerting them to the potential malfunction of the ceiling stand's lifting column that could cause the arm to drop down during patient positioning. Manufacturers were asked to distribute an attached Safety Notice to affected customers. In addition, the firm urged manufacturers to order retrofit kits for all customers and to take any steps needed to ensure that customers install the kits. The kits are free of charge. Manufacturers were also asked to complete a response form and return to the firm. Affected customers were advised of the product problem and instructed to install retrofit kits to avoid risk to patients and to users. If you have any questions, please contact Mr. Wolfgang Bohrer at [email protected].
Quantity in commerce: 667
Distribution: US Nationwide Distribution to accounts in IL, FL, and NY.
Product codes and lots: 7042042 : S/N 1002 to 1787 7042059: S/N 1002 to 1921

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2838-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2837-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17
Z-2838-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17

Product code IYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)