The Recall Desk
HighFDA (Devices)·Z-1045-2016·Announced 2016-03-09

Maquet Extension Device Recalled for Potential Detachment from Operating Table

Maquet is recalling the 1180.19F0 Extension Device because it may unlock and fall from the MAGNUS operating table.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect that could cause the device to fall, posing a risk of harm to patients or staff, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Maquet Medical Systems USA is initiating a field action for the MAQUET Extension Device (Part No 1180.19F0). This device is a table top module manufactured by Maquet GmbH in Germany, designed to support upper and lower extremities during fracture surgery when attached to the Maquet MAGNUS operating table system.

The recall is being conducted because the device may become unlocked from the table top, causing it to fall down. The source text does not report any specific injuries or illnesses associated with this defect.

The recall affects 2 units in the United States (distributed to Arizona and Missouri) and 247 units in foreign countries. The specific units are identified by Catalog Number 1180.19F0 and Serial numbers 00003 and 00004. Users should contact the recalling firm for instructions on correcting the issue.

The recalled product

Product
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 tab
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Surgical Table Accessories
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog Number 1180.19F0
  • Serial numbers 00003 and 00004.

Distribution

Distributed in 2 states:

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