- Recalling firm
- PTW FREIBURG
- Reason for recall
- When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth.
- Affected products (lot / model / serial)
- Model/Catalog Number: S070031.520; UDI-DI: +EPTWS070031Q5200; Software Version 3.1.18;
- Units affected
- 2
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of GA, NY and the countries of Austria, Belgium, Switzerland, Czechia, Germany, Spain, France, Netherlands, Norway, Poland, Portugal, Romania, T¿rkiye, Chile, United Arab Emirates, Saudi Arabia, Mexico, Hong Kong, Brazil, Tajikistan, Ecuador, Iran, Thailand, Serbia, South Africa, Kazakhstan, Algeria.
- Firm location
- Freiburg Im Breisgau, N/A, Germany
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3174-2026
- Recall initiated
- August 4, 2026
- FDA classification date
- September 15, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99720
- Last updated on HTM Vibe
- September 29, 2026