Z-1563-2022Class II

DigitalDiagnost C50 1.1

Name: Z-1563-2022 DigitalDiagnost C50 1.1
Creator: Philips North America Llc
Published: 2022-02-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2022-02-25 / Open, Classified / root cause: software

FDA source

Philips North America Llc began a recall of DigitalDiagnost C50 1.1 on 2022-02-25. 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 the image on the first examination due to an issue in...". 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-1563-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-25
Posted: 2022-09-01
Recalling firm: Philips North America LLC
Product: DigitalDiagnost C50 1.1
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 the 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. (Added 1/3/2023), 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: Software Design Change
Action: Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated July 12, 2022. Philips will schedule an appointment with customers to install the software update at no cost to customers. For questions contact Philips Customer Care Solutions Center 1-800-722-9377.
Quantity in commerce: 11 systems (updated 1/3/2023)
Distribution: Nationwide Distribution including Puerto Rico
Product codes and lots: Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1563-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1563-2022	Class II	Ongoing	FDA Mandated	2022-09-07	2022-08-31

Product code KPR

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)