Reported Jul 20, 2022 · Ongoing
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH
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 Medical Systems DMC GmbH · Development And Manufacturing Ctr. · Hamburg · N/A
Is this the product you have?
- DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
- Lot codes and dates
- Model 712034 Serial Numbers
65 of 65 codes
100010731000110410001108100011091000111910001126100011351000114010001144100011451000115310001156100011571000116310001170100011731000117810001179100011831000119110001192100011991000120010001201100012031000120810001210100012161000122010001231100012321000123410001235100012361000124010001241100012481000125110001261100012621000126410001270100012711000127310001275100012802186134921861369218614022186141821861456218614602186147121861475218614902186149621861497218614982186150121861502
- Model 712034 Serial Numbers
- Amount recalled
- 140 systems in total, (Updated 1/30/2023).
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
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 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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