Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 Used when planning and performing prostate brac
FDA device recall Z-2622-2011 · posted 2011-06-23 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- Interplant Software: If the trajectory needle with a non-zero retraction is adjusted in any of the planning views (Transverse, 3D) and the program is closed and reopened, the Needle Definitions page in the Dose Plan Summary (Plan View) displays the needle with a 0.00 retraction even when the needle is displayed correctly in the planning view. If the Eliminate Leading Spacers function is applied t
- Action taken
- Computerized Medical Systems, Inc. sent a "CUSTOMER ADVISORY" letter dated December 1, 2008, to all affected customers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to discontinue use of the product. There is no workaround at this time. This issue was resolved in Interplant Release 3.4.1 software. All possibly affected users have been shipped the Interplant Release 3.4.1 software in May 2010. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 41
- Distribution
- Worldwide Distribution -- USA (nationwide) including states of: CA, KS, KY, MA, MD, ME, MO, NC, NE, NY, OH, PA, TX and VA and countries of: Australia, Brazil, Chile, China, Germany and Japan.
- Date initiated
- 2008-12-01
- Date posted
- 2011-06-23
- Date terminated
- 2013-04-04
- Location
- Maryland Heights, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTERPLANT (K982696) | Burdette Medical Systems, Inc. | 1999-04-01 |