Reported Sep 7, 2022 · Ongoing
DigitalDiagnost C50 1.1
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- DigitalDiagnost C50 1.1
- Lot codes and dates
- Model Number 712204 Serial Number
210182210187220002210049210051210097210052210053210055220020
- Model Number 712204 Serial Number
- Amount recalled
- 11 systems (updated 1/3/2023)
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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