FDA Medical Device Recalls (openFDA)
Computerized Medical Systems Inc: ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1 Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy has been prescribed. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3-dimensional radiation therapy.
- Recall number
- Z-2645-2011
- Recalling firm
- Computerized Medical Systems Inc
- Product
- ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1 Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy has been prescribed. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3-dimensional radiation therapy.
- Status
- Terminated
- Initiated
- 2009-12-11
- Posted
- 2011-06-23
- Terminated
- 2014-04-01
- Reason
- ERGO Release 1.6.3 is overestimating the MU values.
- Root cause
- Software design
- Action
- 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)
- Quantity
- 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, Malaysia, Poland, Portugal, Serbia, and Spain.
- Lot, serial or model codes
- ERGO++ Release 1.6.3 and 1.6.3.1
- 510(k) numbers
- ["K080601"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 1937649
- Firm city
- Maryland Heights
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28