Recall Z-1744-2022— Philips Medical Systems (Cleveland) Inc
Class II · Ongoing
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2022-08-30. It names one FDA 510(k) clearance: K170086. Product: Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.. 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..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-30
- Firm location
- Gainesville, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.