Z-1329-2020 Class II Ongoing

Recalled by Philips Medical Systems Gmbh, DMC — Hamburg

FDA device recall Z-1329-2020 was initiated by Philips Medical Systems Gmbh, DMC on December 19, 2019 and is designated Class II. 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 sw… The recall status is ongoing (terminated June 18, 2020). Affected quantity: 131.

Recall Details

Product Type
Devices
Report Date
February 26, 2020
Initiation Date
December 19, 2019
Termination Date
June 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
131

Product Description

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 Pattern

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.

Code Information

(domestic only) SN374 SN17081704 SN17121782 SN18011800 SN18081862 SN18061846 SN18111907