CLASS II Device recall · Reported 9 Mar 2016 · FDA Enforcement Report
Maquet Getinge Group 1180.19XO Extension Device recalled
Maquet Cardiovascular Us Sales is recalling Maquet Getinge Group 1180.19XO Extension Device, distributed in Arizona, Missouri. The recall was initiated on 7 Jan 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1045-2016
- FDA event ID
- 73212
- Recalling firm
- Maquet Cardiovascular Us Sales, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jan 2016
- FDA classified
- 3 Mar 2016
- Reported
- 9 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 7 Jan 2016 | Recall initiated by company | |
| 3 Mar 2016 | Classified by FDA | +56 days |
| 9 Mar 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Maquet Getinge Group 1180.19XO Extension Device recalled?
Yes. Maquet Cardiovascular Us Sales recalled Maquet Getinge Group 1180.19XO Extension Device on 7 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-1045-2016.
Why was it 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.
Which lots are affected?
Catalog Number 1180.19F0; Serial numbers 00003 and 00004.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Maquet Cardiovascular Us Sales
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HLS Set Advanced recalled by Maquet Cardiovascular Us Sales | Maquet Cardiovascular Us Sales | Sterility | Nationwide |
| Device | CLASS II | HLS Set Advanced recalled by Maquet Cardiovascular Us Sales | Maquet Cardiovascular Us Sales | Sterility | Nationwide |
| Device | CLASS II | Blood Monitoring Unit (BMU recalled by Maquet Cardiovascular Us Sales | Maquet Cardiovascular Us Sales | Temperature Abuse | Nationwide |
| Device | CLASS II | Yuno II Mobile Operating Table recalled | Maquet Cardiovascular Us Sales | Foreign Material | Nationwide |
| Device | CLASS II | Yuno Mobile Operating Table recalled by Maquet Cardiovascular Us Sales | Maquet Cardiovascular Us Sales | Foreign Material | Nationwide |
Other Masks, Gloves & PPE recalls
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&m Halyard | Other | Nationwide |