CombiDiagnost PCF recalled over fire hazard

Recall date

December 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Philips Medical Systems Gmbh, DMC recalls CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, gener…

Recall number

Z-1329-2020

FDA classification

Class II

Brand / firm

Philips Medical Systems Gmbh, DMC

Sold / distributed

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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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