Recall Z-0548-05 ยท JAK System, X-Ray, Tomography, Computed
E-Z-EM, Inc
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.
| Date | Feb 16, 2005 (initiated Dec 3, 2004) |
| Status | Terminated |
| Reason | 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 | 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. |
| FDA record | Open on fda.gov |