Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
FDA Recall Z-0350-2011 · Posted None
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2010-09-01
Date Terminated2010-12-14
Product Quantity23 units
Reason for Recall
It is possible to do couch corrections twice if both Couch Move Assistant in MOSAIQ and Remote Automatic Table in XVI are configured when in SYNERGISTIQ mode.
Firm Action
Elekta sent an "Important Notice A340" dated September 1, 2010 to all customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to make a decision if XVI or MOSAIQ does the corrective table movement; configure and ensure that the system only uses RATM or CMA for the corrective table movement, when in SYNERGISTIQ mode, and complete and return the IMPORTANT NOTICE Confirmation of Receipt form via fax at +44(0)1293 654401.
If you have any questions contact your local service representative at +44(0)1293 654200.
Root Cause
Other
Distribution Pattern
Nationwide distribution: AZ, CA, DC, IL, KY, MA, MI, MS, NV, NY, OH, OR, PA, VT, and WV.
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.