Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0248-2016 — Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as we

U.S. FDA — Device Enforcement · United States · 2015-08-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0248-2016
Date of alert: 2015-08-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Maquet Cardiovascular Us Sales, Llc
Product category: device
Product type: Devices

Reported risk: Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) for lumbar spine surgery. The hip elements may have a negative effect on patients- venous backflow under certain conditions and may have been a contributing factor to thromboembolic events.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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