# FDA recall Z-1329-2022

> **Philips Medical Systems DMC GmbH** · Class II · device recall initiated 2021-05-19.

## Product

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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1329-2022
- **Recalling firm:** Philips Medical Systems DMC GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-19
- **Report date:** 2022-07-20

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Hamburg, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1329-2022

## Citation

> AI Analytics. FDA recall Z-1329-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1329-2022. Source: US FDA. Licensed CC0.

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