Recall Z-1744-2022 ยท MUJ System, Planning, Radiation Therapy Treatment
Philips Medical Systems (Cleveland) Inc
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
| Date | Sep 15, 2022 (initiated Aug 30, 2022) |
| Status | Open, Classified |
| Reason | When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen. |
| Root cause | Device Design |
| Action | The recalling firm issued letters dated August 2022 via certified mail on 8/30/2022. A black box at the beginning of the letter notates the document contains important information for the continued safe and proper use of the product. The information is to be reviewed with all members of the consignee's staff who need to be aware of the contents of the communication and to understand the implications of the communication. The letter informs the consignee what the problem is and under what circumstances it can occur and contains an embedded photograph of the Edit Prescription screen highlight |
| Quantity | 169 systems |
| Distribution | Distribution was made to CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, OK, RI, SC, TN, TX, and WA. There was government distribution and no military distribution. Foreign distribution was made to Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Jordan, Lebanon, Pola |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170086 | Pinnacle Radiation Therapy Planning System Philips Medical Systems (Cleveland), Inc., Feb 9, 2017 |