—#166243

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.

FDA product code: IYB — Tube Mount, X-Ray, Diagnostic
Device class: Class 1
Medical specialty: Radiology
Affected lot / code info: 7042042 : S/N 1002 to 1787 7042059: S/N 1002 to 1921

Why it was 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.

Root cause (FDA determination)

Device Design

Action the firm took

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 wolfgang.bohrer@siemens-healthineers.com.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

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

Timeline

Recall initiated: 2018-06-29
Terminated: 2019-10-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166243. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.