XiO Radiation Treatment Planning System, XiO Release 4.3.0 through 4.50.00. Used to create treatment plans for any cance
FDA device recall Z-2568-2011 · posted 2011-06-15 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. This can occur when dose is calculated, beams are renumbered, and the dose is re-summed only.
- Action taken
- Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter dated May 2009, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Computerized Medical Systems, Inc have created "patches" to resolve the problem. A User Notice was sent in March 2011, to all users still using the affected software notifying them of the updated software available to correct the problem. This letter was sent by US Mail but no return receipt was included. For further questions, please call (408) 380-8023.
- Root cause
- Software design
- Status
- Terminated
- Product code
- muj
- Quantity affected
- 1116
- Distribution
- Worldwide Distribution -- (USA) nationwide Distribution, including Puerto Rico, and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia, Herzego
- Date initiated
- 2009-05-13
- Date posted
- 2011-06-15
- Date terminated
- 2014-04-09
- Location
- Maryland Heights, MO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XIO RTP SYSTEM (K092132) | Computerized Medical Systems, Inc. | 2009-09-24 |