Intinion 1.5 T MRI Scanner.
FDA device recall Z-0272-05 · posted 2004-12-02 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- There is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.
- Action taken
- A Mandatory Service Letter, dated April 17, 2003, was sent to service technicians instructing the technicans to perform a mandatory safety modification.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 93 units.
- Distribution
- Throughout the United States and to Denmark, England, China, Italy, Mexico, Israel, and Puerto Rico.
- Date initiated
- 2003-04-17
- Date posted
- 2004-12-02
- Date terminated
- 2008-10-29
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFINION ENHANCEMENT PACKAGE (K011296) | Philips Medical Systems (Cleveland), Inc. | 2001-07-19 |
| INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 (K003853) | Philips Medical Systems (Cleveland), Inc. | 2001-02-13 |