Philips Medical Systems (Cleveland) Inc: Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.

Recall number

Z-1744-2022

Recalling firm

Philips Medical Systems (Cleveland) Inc

Product

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

Status

Open, Classified

Initiated

2022-08-30

Posted

2022-09-15

Terminated

not on file

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 highlighting the affected fields. The hazard/harm associated with the issue is described, as well as the affected products and how to identify them. An embedded example of the About screen is contained in the letter to show where to find the affected version number. The actions to be taken by the customer/user in order to prevent risks for patients was provided. The actions include: (a) To avoid exporting an incorrect dose, do not prescribe to Percentage of Point Dose. Only prescribe plans using one of the following options provided in the letter until the software solution is provided by Philips; (b) Circulate the notice to the Head of Medical Physics in the Radiation Oncology Department or to the Department Director with specific instructions that the notice be distributed to all users of the Pinnacle3 Radiation Therapy Planning System so that they are aware of the product issue and associated hazard/harm; (c) Post the notice near the affected Pinnacle3 Radiation Therapy Planning System(s) for ease of reference; and (d) Complete and return the attached response form to Philips via email no later than 30 days from receipt of the letter. The consignee is informed that Philips is currently developing a correction which will be released in the future and once released, Philips will contact the consignee to schedule installation of the software solution to resolve the issue.

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

Lot, serial or model codes

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.

510(k) numbers

["K170086"]

PMA numbers

not on file

Product code

MUJ

Firm FEI

3018004899

Firm city

Gainesville

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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