Philips Medical Systems DMC GmbH Recall 90490
Description: DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Philips Medical Systems DMC GmbH Recall 90490 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-1326-2022 |
| Event ID | 90490 |
| Event Description | DigitalDiagnost 4 High Performance. radiography and fluoroscopy system |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 140 systems in total, (Updated 1/30/2023). |
| Recall 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. |
| Device Classification | 20220720 |
| Device Code Info | Model 712031 Serial Numbers - 10001009 10001111 18000123 19000181 20010235 10001039 17000264 18000263 19000297 |
| Center Classification Date | 20220712 |
| Recall Initiation Date | 20210519 |
| Recalling Firm | Philips Medical Systems DMC GmbH |
| Initial Notification | Letter |
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