Reported Sep 21, 2022 · Ongoing
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 3630 Sw 47th Ave · Gainesville, FL · 32608-7555
Is this the product you have?
Pinnacle3 Radiation Therapy Planning SystemModel numbers 870231 and 870237
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published 87023100884838099081Software version 16.0.4, UDI (01)00884838099081(10)16.0.4.60330 — 0084838103054008848381029650088483810297200884838102989Software version 16.4.2, UDI (01)0084838103054(10)16.4.2.60330, UDI (01)00884838102965(10)16.4.2.60330, UDI (01)00884838102972(10)16.4.2.60315, UDI (01)00884838102989(10)16.4.2.60330 — 00884838103191UDI (01)00884838103191(10)16.4.2.60330 8702370088483810296500884838103566and Software version 16.4.3, UDI (01)00884838102965(10)16.4.3.60360. : Software version 16.4.6, UDI (01)00884838103566(10)16.4.6.21197 — 0088483810356600884838103566and Software version 18.0.1, UDI (01)00884838103566(10)18.0.1.2149 and (01)00884838103566(10)18.0.1.21197. - Amount recalled
- 169 systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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