Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2022 - (Recall #: Z-1744-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 30, 2022

Date Posted: September 21, 2022

Recall Number: Z-1744-2022

Event ID: 90819

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.

Status: Ongoing

Product Quantity: 169 systems

Code Information:

Model 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.

Distribution Pattern:

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, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated