PTW UNIDOS webline Dosimeters Recalled for Potential Radiation Over-Exposure
PTW-Freiburg is recalling PTW UNIDOS webline dosimeters because measurement errors at high dose rates could display too-low doses, potentially leading to radiation over-exposure.
What this means for you
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: The recall involves a risk-of-harm product (radiation over-exposure) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
PTW-Freiburg is recalling 242 units of PTW UNIDOS webline dosimeters, including reference models T10023 and T10022 with Firmware version 2.05. These devices are used for radiation therapy, diagnostic radiology, and health physics. The recall covers specific serial numbers distributed in California, Michigan, Massachusetts, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas, and Wisconsin.
The recall was initiated because measurement errors can occur in some cases, particularly with high dose-per-pulse-rates typical for particle therapy, such as proton therapy. When these high rates are present, individual measurement intervals can be lost without being visible to the user. This results in a dose that is too low being displayed on the monitor, which could lead to radiation over-exposure for the patient or user.
Affected users should check their device serial numbers against the list provided in the official recall notice. If a device is affected, users should contact PTW-Freiburg for instructions on how to proceed. The source text does not specify a remediation method, such as a firmware update or replacement, but users should follow the manufacturer's guidance.
The recalled product
- Product
- PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
- Manufacturer
- PTW-Freiburg
- Affected units
- 242
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 (20)
- serial numbers: **T10021: 000005
- 000019
- 000037
- 000041
- 000047
- 000049
- 000058
- 000066
- 000074
- 000076
- 000079
- 000099
- 000107
- 000125
- 000141
- 000144
- 000158
- 000161
- 000168
- 000175
Distribution
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