# FDA recall Z-1329-2020

> **Philips Medical Systems Gmbh, DMC** · Class II · device recall initiated 2019-12-19.

## Product

CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

## Reason for recall

When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.

## Distribution

Worldwide distribution  US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MI, MN, MO, MT, NC, NJ, NY, OH, TX, UT, VA and countries of Canada, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, China, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Egypt, Ethiopia, France, Germany, Ghana, Hungary, Iran, Italy, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libya,   Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Nigeria, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

## Key facts

- **Recall number:** Z-1329-2020
- **Recalling firm:** Philips Medical Systems Gmbh, DMC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-12-19
- **Report date:** 2020-02-26
- **Termination date:** 2020-06-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1329-2020

## Citation

> AI Analytics. FDA recall Z-1329-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1329-2020. Source: US FDA. Licensed CC0.

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