ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a full

FDA device recall Z-0697-2019 · posted 2019-01-08 · Terminated

Recall details

Recalling firm

Swissray Medical AG

Reason for recall

A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take the load, can break without triggering the safety lock. This can lead to overloading of the safety cable, which is not designed to permanently carry the load of the lifting column or continuously move under load. This could cause material fatigue and cause the arm to drop unexpectedly during patient positioning. If the arm drops unexpectedly, patients and users may be seriously injured.

Action taken

A component of the device was recalled by a supplier (Siemens AG/Siemens Healthcare GmbH), as a result, Swissray Medical AG, sent an "Important Warning / Important Safety Notice" letters dated 11/14/18 to its customers. The letter described the product, problem and actions to be taken. The firm stated safety related retrofits are available for installation to eliminate risk to patients and users.The retrofit aims to completely correct the problem. The customers were instructed to do the following: To mitigate risk to patients and users until the retrofit modification is implemented, users are strongly advised not to move the column up/down directly above the patient, but to instead first perform vertical movement next to the patient, and then horizontally position over the patient at a fixed height. Please ensure that all your users who own the affected products and others who are aware or them receive the safety-related information provided with this safety notice, and comply with the recommendations contained therein. If you have any questions, contact US Agent of Swissray Medical AG, QA/RA Coordinator at 908-372-6408 or email: Deniz.Kortan@swissray.com.

Root cause

Component design/selection

Status

Terminated

Product code

MQB

Quantity affected

3

Distribution

Worldwide distribution: US distribution to states of: IL and MA and countries of: Czech Republic, Germany, Poland and Peru.

Date initiated

2018-11-14

Date posted

2019-01-08

Date terminated

2021-09-01

Location

Hochdorf, Switzerland

Related 510(k) clearances