Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

HANAULUX 2004 IXL cupola, P/N: 56076868 Intended to provide visible illumination for the surgical field or for the examination of the patient.

FDA Recall Z-0182-2010 · Posted 2009-11-12

Recalling FirmMAQUET Inc.
Recall StatusTerminated
Product CodeFTD
Date Initiated2009-10-07
Date Terminated2012-06-04
Product Quantity3

Reason for Recall

Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.

Firm Action

Urgent Device Correction letters, dated October 7, 2009, were sent out by FedEx. The letter identified the affected products and asked customers to call 1-888-627-8383 #1, if they have any questions. The letter also provided a Technical Description along with a Customer Fax Response form. The letter stated the potential hazard and recommended precaution. If customers need additional info or have any questions they should contact their local MAQUET representative.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K895715HANAULUX(R) 2000W.C. Heraeus GmbH · 1989-10-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑