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

Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. 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-0548-05 · 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.

↑