Pinnacle3 Radiation Therapy Planning System, software version 9.0. Model # Description 453560446041 Pinnacle3 version 9.
FDA device recall Z-0594-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland), Inc.
- Reason for recall
- Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry.
- Action taken
- Consignees were sent on 11/18/11 a Philips "Urgent Medical Device Correction" letter dated 2011 Nov 16. The letter identified the affected product and described the Problem, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer/User, Actions Planned by Philips and Further information and Support. If customers observed the issue, they were to manually make the suggested change. In addition, customers were to place the letter in the Instructions for Use until otherwise notified. The firm will deliver 9.2 software release free of charge. Customers in North America are to contact Customer Care Solutions Center at 1-800-722-9377, if they have questions or need support concerning the recall.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 715 (463 US)
- Distribution
- Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, O
- Date initiated
- 2011-11-18
- Date posted
- 2012-01-11
- Date terminated
- 2014-02-28
- Location
- Fitchburg, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K041577) | Adac Laboratories | 2004-06-25 |