Recall Z-1944-2012 ยท IYE Accelerator, Linear, Medical
Impac Medical Systems Inc
MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
| Date | Jul 6, 2012 (initiated Jun 8, 2012) |
| Status | Terminated |
| Reason | Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero. |
| Root cause | Software design |
| Action | A User Notice began being distributed on June 8, 2012. This will be followed by contact at each site by IMPAC support to determine if the site is affected by this issue, and if so, the upgraded version will be suggested. The Notice identified the affected device, the problem, the clinical impact, along with the interim mitigations and the final resolution. Users are encouraged to monitor daily delivery and recordings of treatments to be sure that the Wedge Motor Units treatments are properly delivered. The letter also recommends that treatment charts be checked weekly and that users not ov |
| Quantity | 11 affected sites |
| Distribution | Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom. |
| 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 |