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U.S. Department of Health and Human Services

Class 2 Device Recall 3D TOP Ceiling Stand

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  Class 2 Device Recall 3D TOP Ceiling Stand see related information
Date Initiated by Firm June 29, 2018
Create Date August 17, 2018
Recall Status1 Terminated 3 on October 04, 2019
Recall Number Z-2837-2018
Recall Event ID 80735
Product Classification Tube mount, x-ray, diagnostic - Product Code IYB
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 vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.
Code Information 3070039: S/N 2271 to 2793 3074486: S/N 1812 to 3036 3070013: S/N 3967 to 5042 3070021: S/N 3852 to 4719 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Ms. Anastasia Sokolova
610-219-4834
Manufacturer 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.
FDA Determined
Cause 2		 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 wolfgang.bohrer@siemens-healthineers.com.
Quantity in Commerce 699
Distribution US Nationwide Distribution to accounts in IL, FL, and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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