ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Rev
FDA device recall Z-0819-05 · posted 2005-05-11 · Terminated
Recall details
- Recalling firm
- CTI PET Systems Inc
- Reason for recall
- Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.
- Action taken
- Written notification via certified US Mail was sent out beginning 04/05/2005 to distributors and end users (with whom CTI had a service contract) to advise them of the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 80 units
- Distribution
- Nationwide, Canada, the Netherlands, Ireland & Denmark
- Date initiated
- 2005-04-05
- Date posted
- 2005-05-11
- Date terminated
- 2009-09-11
- Location
- Knoxville, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECAT PET SCANNER (K003241) | Cti Pet Systems, Inc. | 2000-12-13 |
| ECAT ACCEL PET SCANNER (K002584) | Cti Pet Systems, Inc. | 2000-11-16 |
| ECAT EXACT & ECAT EXACT HR+ (K962797) | Cti Pet Systems, Inc. | 1996-10-15 |