Z-2357-2021Class II

CombiDiagnost R90 Software Version R1.0 and R1.1

Name: Z-2357-2021 CombiDiagnost R90 Software Version R1.0 and R1.1
Creator: Philips Medical Systems Gmbh, DMC
Published: 2020-07-22
License: https://open.fda.gov/license/

Philips Medical Systems DMC GmbH / initiated 2020-07-22 / Open, Classified / root cause: software

FDA source

Philips Medical Systems Gmbh, DMC began a recall of CombiDiagnost R90 Software Version R1.0 and R1.1 on 2020-07-22. FDA classified it as Class II and gives the reason as "Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2357-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-22
Posted: 2021-08-28
Recalling firm: Philips Medical Systems DMC GmbH
Product: CombiDiagnost R90 Software Version R1.0 and R1.1
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips sent customers an Electronic Product Radiation Correction letter dated July 14, 2021. The letter identified the affected product, problem and actions to be taken. Philips plans to correct the defect at no cost to customers by implementing a field correction involving the installation of a software update. For questions contact the Customer Care Solutions Center 1-800-722-9377 and reference FCO70900051.
Quantity in commerce: 322 systems; 66 in US
Distribution: US Nationwide Distribution
Product codes and lots: Model 706100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2357-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2357-2021	Class II	Ongoing	FDA Mandated	2021-09-08	2021-08-28

Product code JAA

K203087Class IICombiDiagnost R90Philips Medical Systems Dmc GmbH / cleared 2020-12-03

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)