DigitalDiagnost C50 1.1 recallZ-1563-2022 · Philips North America Llc · initiated Feb 25, 2022
Class II Open, Classified All recalls posted in September 2022
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-1563-2022
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Feb 25, 2022
- Posted by the FDA
- Sep 1, 2022
- Recalling firm
- Philips North America Llc
- Quantity
- 11 systems (updated 1/3/2023)
- Product code
- KPR
- FDA submissions
- K163410, K201725
- Distribution
- Nationwide Distribution including Puerto Rico
Product description
DigitalDiagnost C50 1.1
Code information (models, lots, serial numbers)
Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020
Other devices under the same FDA submission
2 devices cleared under K163410, K201725 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, stationary1 recall8 reports
- DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, stationary1 recall5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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