The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including
FDA device recall Z-1212-2007 · posted 2007-09-25 · Terminated
Recall details
- Recalling firm
- Philips Nuclear Medicine, Inc.
- Reason for recall
- Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction
- Action taken
- All customers will receive an August 21, 2007, Customer Advisory Notification letter notifying them of the issue and the steps required to avoid the issue. Return receipts will be tracked. This is a short-term fix, a long term software fix will be issued shortly by the firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 1,407
- Distribution
- Worldwide Distribution; USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD,
- Date initiated
- 2007-08-21
- Date posted
- 2007-09-25
- Date terminated
- 2011-12-17
- 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 |