ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1 Product Usage: Used to create
FDA device recall Z-2645-2011 · posted 2011-06-23 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- ERGO Release 1.6.3 is overestimating the MU values.
- Action taken
- Computerized Medical Systems, Inc. sent an "USER NOTIFICATION" dated December 11, 2009, to all affected customers. The notice identified the product, problem and suggested a workaround to minimize the risk. The notice stated that this workaround does NOT substitute the need for regular Quality Assurance. Customers are instructed to review page 39 of user manual for further explanation of warnings. Customers were asked to complete the Notice for Customer section and return to 3D Line Medical System. This issue has been resolved in Release 1.7.0 and above. No follow-up notice will be distributed to customers. For further information please contact: CMS Software (314) 812-4460 (St Louis Office)
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 45
- Distribution
- Nationwide distribution to medical facilities in CA, MO, NC, ND, NV, NY, OH, OK, TX, and WA. Foreign distribution was made to Brazil, Cuba, Czech Republic, France, Germany, India, Italy, Japan, Malays
- Date initiated
- 2009-12-11
- Date posted
- 2011-06-23
- Date terminated
- 2014-04-01
- Location
- Maryland Heights, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ERGO++ VERSION 1.7 (K080601) | 3D Line Medical Systems S.R.L. | 2008-06-06 |