Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
PTW FREIBURG · 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…
Open FDA's page for this record- Cfres ID
- 222289
- Product res number
- Z-3174-2026
- Event date initiated
- 2026-08-04
- Event date posted
- 2026-09-15
- Recall status
- Open, Classified
- Res event number
- 99720
- Product code
- IYE
- Product description
- Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
- Code info
- Model/Catalog Number: S070031.520; UDI-DI: +EPTWS070031Q5200; Software Version 3.1.18;
- Firm FEI number
- 3007360740
- Recalling firm
- PTW FREIBURG
- Address 1
- Lorracher Str. 7 7 lorracher str.
- City
- Freiburg Im Breisgau
- Country
- Germany
- Root cause description
- Software design
- Product quantity
- 2
- 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.
- Action
On August 13, 2026 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: If a user is unsure whether a bolus must be used for treatment or not, VERIQA RT MonteCarlo 3D must not be used as the source of information. The user must rely exclusively on the information from the TPS and from the patient record to determine whether a bolus is used for treatment or not. VERIQA RT MonteCarlo 3D must not have any influence on the treatment workflow or on the treatment plan. This error will be fixed in the next VERIQA RT MonteCarlo 3D release. Please forward this notice to everyone in your organization, or in any other organization using VERIQA RT MonteCarlo 3D version 3.1.18, who needs to be aware of it.
- 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.
- K numbers
- K213370
- Harmonized identifiers (openFDA)
- Device name
- Accelerator, Linear, Medical
- Medical specialty description
- Radiology
- Regulation number
- 892.5050
- Device class
- 2
- K number
- K260792, K062611, K180595, K081218, K952108, K991107, K052391, K231317, K963624, K091209, K933117, K193431, K903139, K920455, K150706, K182138, K211001, K961484, K961400, K812032, K070094, K800792, K982713, K162629, K943406, K935411, K940145, K151097, K100691, K060737, K141230, K964840, K180586, K241937, K192405, K100115, K123808, K981313, K212114, K071673 +698 more
- Registration number
- 1722661, 3006073271, 9613183, 3003094912, 1647149, 1721113, 1932738, 3004608878, 9710332, 9681134, 3015232217, 3018094310, 2155, 1530561, 3022973841, 3022719374, 3003793371, 3004637983, 3012631246, 3027080417, 3013410552, 3009302839, 2134494, 3033484057, 2183744, 3005099803, 3012039133, 3008317830, 3015496236, 3009649442, 3004753785, 3002807314, 1651102, 3010625741, 3016602874, 3006405073, 1220477, 3004832819, 2431392, 3004363352 +75 more
- FEI number
- 1000143606, 1000306139, 3006073271, 3003094912, 1721113, 3002802883, 3002806900, 3004608878, 3015232217, 3018094310, 2155, 3022973841, 3022719374, 3003793371, 3002913962, 3004637983, 3012631246, 3027080417, 3013410552, 3009302839, 3033484057, 2183744, 3005099803, 1000521490, 3012039133, 3008317830, 1000518731, 3015496236, 3009649442, 3004753785, 3001236129, 3002807314, 3010625741, 3016602874, 3006405073, 1220477, 3000253133, 3004832819, 1000115748, 1000113153 +75 more