Impac Medical Systems Sequencer Product Usage: The intended us of Sequencer is to assists in the process of patient trea
FDA device recall Z-0052-2012 · posted 2011-10-17 · Terminated
Recall details
- Recalling firm
- Impac Medical Systems Inc
- Reason for recall
- Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq.
- Action taken
- " Impac Medical Systems Inc., sent an USER NOTICE letter to all affected consignees on September 20, 2011. The letters identified the source characterization error, clinical impact, and final resolution. The letter states that Elekta Support will follow up with each consignee and remotely correct the source characterization. Customers were instructed to sign, date and return the attached Confirmation of Receipt Form by one of the three ways indicated. The letter instructs consignees to distribute this notice to any and all users of IMPAC software that may potentially be affected by the issue. For questions, concerns, and requests for upgrade, email support@impac.com or call. The letter provided consignees with a complete list of contact information..
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 11 devices
- Distribution
- Nationwide Distribution (USA) - including the states of: AZ, CA, FL, NJ, NY, NV, TX, VA and WA.
- Date initiated
- 2011-09-09
- Date posted
- 2011-10-17
- Date terminated
- 2012-03-06
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEQUENCER (K981313) | Impac Medical Systems, Inc. | 1998-07-09 |