Gyroscan MRI
FDA Recall Z-0981-2007 · Posted 2007-06-27
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Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeLNH
Date Initiated2007-04-30
Date Terminated2011-09-21
Product Quantity293 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Units were distributed throughout the US to 1,078 hospitals and medical centers.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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