The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1744-2022·Announced 2022-09-21

Pinnacle3 Radiation Therapy Planning System dose-calculation software error

Philips Pinnacle3 radiation therapy planning systems may export incorrect dose information when multiple beams are used with certain Edit Prescription settings. 169 systems are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall affecting a high-risk medical device (radiation therapy planning system) with a software bug that causes incorrect dose calculations. No injuries or illnesses have been reported, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported'.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 169 Pinnacle3 Radiation Therapy Planning System units (Models 870231 and 870237). The recall is due to a software error affecting dose calculation and export.

When computing a radiation dose in the system with multiple beams attached to a prescription and certain options selected on the Edit Prescription screen, the exported dose information is incorrect. This applies to Model 870231 (software versions 16.0.4, 16.4.2, and 16.4.3) and Model 870237 (software versions 16.4.6 and 18.0.1).

Affected systems were distributed across 20 US states (CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, OK, RI, SC, TN, TX, WA) and 20 countries including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Jordan, Lebanon, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, and United Kingdom.

The recalled product

Product
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Radiation Therapy Planning
Hazard
Affected units
169

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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

Distributed in 21 states:

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