Recall Z-2200-2015 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Electronics North America Corporation
Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.
| Date | Jul 22, 2015 (initiated Jul 31, 2014) |
| Status | Terminated |
| Reason | Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl. |
| Root cause | Software design |
| Action | Consignees were sent on 7/31/2014 a Philips "Urgent Field Safety Notice" dated 2014-July 20. The letter described the problem, product involved in the recall and the action that should be taken by the customers. For questions contact Customer Care Solutions Center at 1-800-722-9377. UPDATE: A second Philips letter dated 2 July 2015 was sent in August 6, 2015. This letter updated the recall to incorporate the additional products being recalled. |
| Quantity | 1642 |
| Distribution | Worldwide Distribution-US: All states in the US including DC and PR. OUS: Australia, Austria, Bangladesh, Belgium, Brazil, China, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands,New Zealand, Oman, Philippines, Singapore, South Africa, South |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041577 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Adac Laboratories, Jun 25, 2004 |