FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Intinion 1.5 T MRI Scanner.
- Recall number
- Z-0272-05
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Intinion 1.5 T MRI Scanner.
- Status
- Terminated
- Initiated
- 2003-04-17
- Posted
- 2004-12-02
- Terminated
- 2008-10-29
- Reason
- 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.
- Root cause
- Other
- Action
- A Mandatory Service Letter, dated April 17, 2003, was sent to service technicians instructing the technicans to perform a mandatory safety modification.
- Quantity
- 93 units.
- Distribution
- Throughout the United States and to Denmark, England, China, Italy, Mexico, Israel, and Puerto Rico.
- Lot, serial or model codes
- Serial Numbers ZA101-ZA188, ZA190-192, ZA195, ZA200, ZA201.
- 510(k) numbers
- ["K003853","K011296"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28