[Recalled] ProxiDiagnost N90. radiography and fluoroscopy system — Following a system restart where the Table Height 2 (TH2) is the default settin… | FDA 2021-05-19
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | ProxiDiagnost N90. radiography and fluoroscopy system |
|---|---|
| Brand / manufacturer | Philips Medical Systems DMC GmbH |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1325-2022 |
| Country of notice | Germany |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 19 May 2021 |
| EAN / barcode | 10001002 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in Germany and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Philips Medical Systems DMC GmbH
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.