FDA Medical Device Recalls (openFDA)
Philips Medical Systems: Gyroscan NT-Intera 1.5T
- Recall number
- Z-1200-03
- Recalling firm
- Philips Medical Systems
- Product
- Gyroscan NT-Intera 1.5T
- Status
- Terminated
- Initiated
- 2002-05-02
- Posted
- 2003-09-12
- Terminated
- 2005-04-11
- Reason
- Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil
- Root cause
- Other
- Action
- The firm issued a Field Change Order to their field personnel instructing them to add new labeling to the User Manual. 05/02/2002 A letter was issued to customers.
- Quantity
- see above
- Distribution
- The firm distributed units to hospitals and medical centers nationwide.
- Lot, serial or model codes
- Serial numbers provided above
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- 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