PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam radiation therapy treatments.
FDA device recall Z-1109-2010 · posted 2010-03-16 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- The new "DICOM CT with Body Outline" method to create a patient case in PrecisePLAN 2.15 may produce incorrect results for some customers, given several input conditions encountered in the field. Discontinue use of this method of creating a patient case until FCO 772 00 540 064, (entitled "Update for Patient creation method using DICOM CT with Body Outline"), is received from Elekta to update th
- Action taken
- Important Notice A297, "PrecisePLAN release 2.15 with DICOM CT with Body Outline" method of patient creation (dated May 8, 2007) was distributed to all customers. An additional Field Change Order 540 073, dated September 30, 2008 was distributed to customers. Important Notice A316 "Cancellation of Important Notice for PrecisePLAN" was issued. The Important Notice instructed affected users to dispose of Important Notice A297 and replace it with Important Notice A316. If you have any questions regarding the notification, please contact your local Elekta representative directly.
- Root cause
- Other
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 280 units
- Distribution
- United States -- (AL, AK, AZ, AR, CA, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, , NC, OH, OK,OR, PA, SC, TN, TX, VA, WA and WI) & France.
- Date initiated
- 2008-09-30
- Date posted
- 2010-03-16
- Date terminated
- 2010-12-28
- Location
- Norcross, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRECISEPLAN 2.0 (K022411) | Precision Therapy Intl., Inc. | 2002-09-20 |