Recall Z-0169-2013 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.
| Date | Oct 30, 2012 (initiated Sep 18, 2012) |
| Status | Terminated |
| Reason | A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ. |
| Root cause | Device Design |
| Action | The firm, MOSAIQ, sent an "IMPORTANT SAFETY NOTICE- LINMSQ0003" was sent to consignees/customers on September 18, 2012. The notice described the product, problem and actions to be taken. The customers were instructed to check their Department Setup configuration settings, and re-enable the Field Edit Delta Display feature if they have disabled it. Note: sites can take this action without an upgrade/patch. The customers were also instructed to complete and return the CONFIRMATION OF RECEIPT form via fax to: 702-992-5002 in US or +44 (0)1293 654401 in OUS, Attn: Elekta OIS Support; scan and e |
| Quantity | 300 |
| Distribution | Worldwide distribution: USA (nationwide) and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120067 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Feb 28, 2012 |