FDA (Devices) recall action 92647

Landauer recalled 38 products on 2023-09-20

The FDA (Devices) publishes a recall like this one as 38 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 38 pages.

Products: 38
Announced: 2023-09-20
Critical: 0
Units: 1,678,258

Why these products were recalled

LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–38 of 38

HighFDA (Devices)··2023-09-20
Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
Landauer is recalling nanoDot D2DXS radiation dosimeters that may not accurately measure radiation exposure. Some units may fall outside the specified ±5.5% accuracy range due to a potential defect in the optical stimulated luminescence material.
Product
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeters may be outside accuracy specifications
Landauer is recalling nanoDot D2DNS radiation dosimeters that may be outside the specified +/-5.5% accuracy range. The issue involves a potential non-conformance in the optical measurement material.
Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeters recalled for measurement inaccuracy
Landauer is recalling QC nanoDot radiation dosimeters worldwide due to potential inaccuracy in radiation dose measurements. Some units may read outside the specified ±5.5% accuracy range.
Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; c) 04218-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeters potentially outside accuracy specifications
Landauer is recalling nanoDot radiation dosimeters due to a potential manufacturing defect in the optical measurement material. Some units may fall outside the specified ±5.5% accuracy range.
Product
Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c) 18125-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot Radiation Dosimeter Recalled for Accuracy Defect
Landauer is recalling nanoDot radiation dosimeter adapters (EU Model VINLADA003) worldwide because some units may provide dosimetry readings outside the specified +/-5.5% accuracy range due to a non-conformance in the optical measurement material.
Product
Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Radiation Dosimeter May Provide Inaccurate Dose Measurements
Landauer is recalling certain nanoDot D2DNS radiation dosimeters because they may measure radiation exposure outside the specified accuracy range. Approximately 5,958 units worldwide are affected.
Product
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot D2DNS Radiation Dosimeters Recalled for Accuracy Non-Conformance
Landauer recalled 135 nanoDot D2DNS radiation dosimeters worldwide due to potential accuracy deviations outside the specified ±5.5% range in optical stimulated luminescence material.
Product
nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
Landauer is recalling 18,638 nanoDot radiation monitoring dosimeters worldwide. Some units may measure radiation exposure outside the specified ±5.5% accuracy range, potentially affecting occupational safety monitoring.
Product
nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
Landauer is recalling nanoDot A radiation dosimeters (Model 03501-000) because some units may measure radiation exposure outside the acceptable accuracy range. A potential non-conformance in the optical material was identified during investigation.
Product
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeters recalled for accuracy drift
Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may read outside the specified ±5.5% accuracy range due to a potential non-conformance in the Optical Stimulated Luminescence material.
Product
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Landauer nanoDot radiation dosimeters recalled for measurement accuracy defect
Landauer recalled 5,760 nanoDot D2DNN radiation dosimeter units worldwide due to potential inaccuracy in radiation measurement. Some units may read outside the specified +/-5.5% accuracy range due to a defect in the optical stimulated luminescence material.
Product
nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Radiation Dosimeter Accuracy Issue Recall for nanoDot D2DNS
Landauer is recalling nanoDot D2DNS radiation dosimeters due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.
Product
nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states
HighFDA (Devices)··2023-09-20
Radiation Dosimeter Recall: nanoDot D2DXN Units May Have Inaccurate Readings
Landauer is recalling nanoDot D2DXN radiation dosimeters worldwide due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.
Product
nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Distribution
0 states