Recall record at a glance
| Official record | Z-1329-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Philips Medical Systems Gmbh, DMC |
| Report date | Feb 26, 2020 |
| Recall initiation date | Dec 19, 2019 |
| Quantity | 131 |
| Location | Hamburg, Germany |
Official product description
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Why the product 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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