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Terminated

Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.

FDA Recall Z-0549-05 · Posted 2005-02-16

Recalling FirmE-Z-EM, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2004-12-03
Date Terminated2007-08-24

Reason for Recall

Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.

Firm Action

On 12/3/04, "Urgent: Medical Device Recall" Letters (dated 12/3/04), were mailed via return receipt.

Root Cause

Other

Distribution Pattern

Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom, France, The Netherlands and Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825E-Z-Em, Inc. · 2003-06-19K011160E-Z EM PERCUPUMP 2001 CT INJECTORE-Z-Em, Inc. · 2001-05-16

Official Source

View FDA Recall →

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

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