Product Safety Recalls

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Philips Medical Systems (Cleveland) Inc Recall 90819

Description: Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.

Philips Medical Systems (Cleveland) Inc Recall 90819 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1744-2022
Event ID90819
Event DescriptionPinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Product TypeDevices
DistributionDistribution 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, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, and United Kingdom.
Quantity169 systems
Recall ReasonWhen 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.
Device Classification20220921
Device Code InfoModel 870231: Software version 16.0.4, UDI (01)00884838099081(10)16.0.4.60330; Software 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; UDI (01)00884838103191(10)16.4.2.60330; and Software version 16.4.3, UDI (01)00884838102965(10)16.4.3.60360. Model 870237: Software version 16.4.6, UDI (01)00884838103566(10)16.4.6.21197; and Software version 18.0.1, UDI (01)00884838103566(10)18.0.1.2149 and (01)00884838103566(10)18.0.1.21197.
Center Classification Date20220915
Recall Initiation Date20220830
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Initial Notification Letter
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