Recall archive / FDA device enforcement
DigitalDiagnost C50 1.1 — FDA record Z-1563-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- DigitalDiagnost C50 1.1
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Philips North America Llc
- Quantity
- 11 systems (updated 1/3/2023)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1563-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide Distribution including Puerto Rico
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 7, 2022
- Recall initiation date
- Feb 25, 2022
- Center classification date
- Aug 31, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.