Recall record at a glance
| Official record | Z-1045-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Maquet Cardiovascular Us Sales, LLC |
| Report date | Mar 9, 2016 |
| Recall initiation date | Jan 7, 2016 |
| Quantity | 2 within US; 247 OUS |
| Location | Wayne, NJ, United States |
Official product description
Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table.
Why the product was recalled
MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0). The Extension Device is manufactured by Maquet GmbH, in Germany, and is a table top module for use with the Maquet MAGNUS operating table system. Maquet GmbH was made aware of a potential issue that can result in the Extension Device becoming unlocked from the table top, causing it to fall down.
Distribution information
Worldwide Distribution - US including AZ and MO. Foreign distribution to Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, and Venezuela.
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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