FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Panorama 1.0T MRI
- Recall number
- Z-0984-2007
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Panorama 1.0T MRI
- Status
- Terminated
- Initiated
- 2007-04-30
- Posted
- 2007-06-27
- Terminated
- 2011-09-21
- Reason
- Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.
- Root cause
- Other
- Action
- On 4/30/07 Philips sent an Urgent Device Correction letter dated April 25, 2007 via certified mail to customers. The letter advises customers of the issue and that that a representative will visit the sites, inspect and correct the problem if indicated.
- Quantity
- 56 units
- Distribution
- Units were distributed throughout the US to 1,078 hospitals and medical centers.
- Lot, serial or model codes
- Site #s: 521810, 533745, 533860, 533900, 534276, 534278, 535230, 535273, 535664, 536972, 537852, 538574, 538616, 539265, 539374, 539514, 540482, 541065, 541851, 542236, 542244, 543822, 544039, 544148, 544696, 544723, 545034, 545143, 545732, 545902, 545918, 545981, 546206, 546594, 546654, 546722, 546728, 547843, 547897, 548040, 548041, 548064, 549389, 549909, 550324, 550358, 550398, 550439, 550449, 550621, 551025, 551583, 552453, 552526, 552609 and 47480028.
- 510(k) numbers
- ["K041602"]
- 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