# FDA recall Z-0239-2019

> **Philips Medical Systems Gmbh, DMC** · Class II · device recall initiated 2018-09-19.

## Product

Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System  Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.

## Reason for recall

Stitching run on SkyPlate detector interrupted intermittently;  Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline

## Distribution

Worldwide distribution - US Nationwide and countries of   Canada  Argentina  Australia  Austria  Bangladesh  Belgium  Bolivia  Brazil  Chile  China  Colombia  Czech Republic  Denmark  Egypt  Finland  France  French Guiana  Germany  Guadeloupe  Hong Kong  Hungary  India  Indonesia  Iran  Israel  Italy  Japan  Jordan  Korea, Republic of  Kuwait  Kyrgyzstan  Latvia  Luxembourg  Maldives  Martinique  Mexico  Netherlands  New Zealand  Norway  Panama  Peru  Poland  Portugal  Qatar  Romania  Russian Federation  Saudi Arabia  Singapore  Slovenia  South Africa  Spain  Sweden  Switzerland  Taiwan  Thailand  Turkey  United Arab Emirates  United Kingdom

## Key facts

- **Recall number:** Z-0239-2019
- **Recalling firm:** Philips Medical Systems Gmbh, DMC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-19
- **Report date:** 2018-10-31
- **Termination date:** 2023-08-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hamburg, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0239-2019

## Citation

> AI Analytics. FDA recall Z-0239-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0239-2019. Source: US FDA. Licensed CC0.

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