Z-1328-2022Class II

DigitalDiagnost C90 High Performance. radiography and fluoroscopy system

Name: Z-1328-2022 DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
Creator: Philips Medical Systems DMC GmbH
Published: 2021-05-19
License: https://open.fda.gov/license/

Philips Medical Systems DMC GmbH / initiated 2021-05-19 / Open, Classified / root cause: software

FDA source

Philips Medical Systems DMC GmbH began a recall of DigitalDiagnost C90 High Performance. radiography and fluoroscopy system on 2021-05-19. FDA classified it as Class II and gives the reason as "Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the...". 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-1328-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-19
Posted: 2022-07-12
Recalling firm: Philips Medical Systems DMC GmbH
Product: DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
Product code: KPR System, X-Ray, Stationary
Reason for recall: Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips sent an Electronic Product Radiation Defect notification letter dated May 25, 2022 to affected customers. Philips will schedule an appointment with customers to install the software update. Philips will, without charge bring the product into compliance. Customers were instructed to complete and return the attached response form to Philips. For further information or support concerning this issue, please contact Philips Customer Care Solutions Center: 1-800-722-9377 and reference FCO71200223 for impacted DigitalDiagnost systems or FCO70600109 for impacted ProxiDiagnost systems.
Quantity in commerce: 140 systems in total, (Updated 1/30/2023).
Distribution: US Nationwide Distribution
Product codes and lots: Model 712034 Serial Numbers 10001073 10001104 10001108 10001109 10001119 10001126 10001135 10001140 10001144 10001145 10001153 10001156 10001157 10001163 10001170 10001173 10001178 10001179 10001183 10001191 10001192 10001199 10001200 10001201 10001203 10001208 10001210 10001216 10001220 10001231 10001232 10001234 10001235 10001236 10001240 10001241 10001248 10001251 10001261 10001262 10001264 10001270 10001271 10001273 10001275 10001280 21861349 21861369 21861402 21861418 21861456 21861460 21861471 21861475 21861490 21861496 21861497 21861498 21861501 21861502 21861525 21861531 21861542 22860038 22860118

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1328-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1325-2022	Class II	Ongoing	FDA Mandated	2022-07-20	2022-07-12
Z-1326-2022	Class II	Ongoing	FDA Mandated	2022-07-20	2022-07-12
Z-1327-2022	Class II	Ongoing	FDA Mandated	2022-07-20	2022-07-12
Z-1328-2022	Class II	Ongoing	FDA Mandated	2022-07-20	2022-07-12
Z-1329-2022	Class II	Ongoing	FDA Mandated	2022-07-20	2022-07-12

Product code KPR

K202564Class IIDigitalDiagnost C90Philips Medical Systems Dmc GmbH / cleared 2020-09-30

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)