Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling
FDA device recall Z-0549-05 · posted 2005-02-16 · Terminated
Recall details
- Recalling firm
- E-Z-EM, Inc
- 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.
- Action taken
- On 12/3/04, "Urgent: Medical Device Recall" Letters (dated 12/3/04), were mailed via return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Distribution
- Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom, France, The Netherlands and Korea.
- Date initiated
- 2004-12-03
- Date posted
- 2005-02-16
- Date terminated
- 2007-08-24
- Location
- Westbury, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 (K031571) | E-Z-Em, Inc. | 2003-06-19 |
| E-Z EM PERCUPUMP 2001 CT INJECTOR (K011160) | E-Z-Em, Inc. | 2001-05-16 |