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Terminated

Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.

FDA Recall Z-2338-2008 · Posted 2008-09-23

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeBSZ
Date Initiated2008-07-07
Date Terminated2010-03-08
Product Quantity111 units

Reason for Recall

The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.

Firm Action

The firm has issued a MEDICAL DEVICE RECALL letter dated 7/7/08 to its customers via certified mail. The letter informs them of the problem and to exercise care when using the device until it has been retrofitted. Contact Drager Medical at 1-800-543-5047, #4 for assistance.

Root Cause

Process control

Distribution Pattern

Nationwide

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.

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