Z-0697-2019Class II

ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus...

Name: Z-0697-2019 ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus...
Creator: Swissray Medical AG
Published: 2018-11-14
License: https://open.fda.gov/license/

SWISSRAY Medical, AG / initiated 2018-11-14 / Terminated / root cause: design

FDA source

Swissray Medical AG began a recall of ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system... on 2018-11-14. FDA classified it as Class II and gives the reason as "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...". 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-0697-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-14
Posted: 2019-01-08
Terminated: 2021-09-01
Recalling firm: SWISSRAY Medical, AG
Product: ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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: [email protected].
Quantity in commerce: 3
Distribution: Worldwide distribution: US distribution to states of: IL and MA and countries of: Czech Republic, Germany, Poland and Peru.
Product codes and lots: Serial Numbers: S403088, S403089, S403165

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0697-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0697-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-16	2019-01-08

Product code MQB

K050718Class IIDdrcombi TraumaSwissray International, Inc. / cleared 2005-05-26

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)