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

Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969.

FDA Recall Z-1315-2008 · Posted 2008-07-16

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeBSZ
Date Initiated2008-02-05
Date Terminated2008-09-09
Product Quantity196 UNITS

Reason for Recall

Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.

Firm Action

Consignees were notified by an Urgent Medical Device Recall letter sent on 2/7/08. The letter informed users that the recalling firm will contact them to schedule appointments to inspect any potentially affected machines. The letter instructed users to continue using the machines, before the inspection, making sure to carefully follow the warnings in the instruction manual. If a caster on the machine appears unstable before the inspection is conducted, users were advised to contact the recalling firm. For additional information, contact 1-800-543-5047.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042419FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEMDraeger Medical, Inc. · 2004-10-08

Official Source

View FDA Recall →

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

↑