Philips Medical Systems North America Co. Phillips began a recall of Panorama 1.0T MRI on . The reason FDA records is "Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0984-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Philips North America LLC
- Product
- Panorama 1.0T MRI
- Product code
- LNH System, Nuclear Magnetic Resonance Imaging
- Reason for recall
- Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.
- FDA 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 in commerce
- 56 units
- Distribution
- Units were distributed throughout the US to 1,078 hospitals and medical centers.
- Product codes and lots
- 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.
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