Z-0549-05

Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector...

Name: Z-0549-05 Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector...
Creator: E-Z-EM, Inc
Published: 2004-12-03
License: https://open.fda.gov/license/

E-Z-EM, Inc / initiated 2004-12-03 / Terminated / root cause: manufacturing process

FDA source

E-Z-EM, Inc began a recall of Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number... on 2004-12-03. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0549-05
Status: Terminated
Initiated: 2004-12-03
Posted: 2005-02-16
Terminated: 2007-08-24
Recalling firm: E-Z-EM, Inc
Product: 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.
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: manufacturing process
FDA root cause: Other
Action: On 12/3/04, "Urgent: Medical Device Recall" Letters (dated 12/3/04), were mailed via return receipt.
Distribution: Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom, France, The Netherlands and Korea.
Product codes and lots: No lot #s or serial #s assigned to this accessory

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)