Recall Z-1329-2022— Philips Medical Systems DMC GmbH
Class II · Ongoing
Class II FDA medical device recall by Philips Medical Systems DMC GmbH, initiated 2021-05-19. It names one FDA 510(k) clearance: K202564. Product: DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system. 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 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..
- Recalling firm
- Philips Medical Systems DMC GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-05-19
- Firm location
- Hamburg, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.