Z-2567-2023Class II

QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring...

Name: Z-2567-2023 QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring...
Creator: Landauer
Published: 2023-07-12
License: https://open.fda.gov/license/

Landauer / initiated 2023-07-12 / Completed

FDA source

Landauer began a recall of QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimeter used with the microSTAR readers on 2023-07-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-2567-2023
Classification: Class II
Status: Completed
Initiated: 2023-07-12
Posted: 2023-09-12
Recalling firm: Landauer
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
Product code: IYE Accelerator, Linear, Medical
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: Landauer disseminated an URGENT - Medical Device Recall notice to its consignees on 07/12/2023 by US mail and email. The notice explained the problem with the devices, potential risk, and requested the following: Discontinue use of the affected products, destroy used products, and return unused products.
Quantity in commerce: 3570 units
Distribution: Worldwide
Product codes and lots: UDI/DI 0860003399903, all batch numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2567-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2538-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2539-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2540-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2541-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2542-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2543-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2544-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2545-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2546-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2547-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2548-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2549-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2550-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2551-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2552-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2553-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2554-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2555-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2556-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2557-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2558-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2559-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2560-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2561-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2562-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2563-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2564-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2565-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2566-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2567-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2568-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2569-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2570-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2571-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2572-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2573-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2574-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12
Z-2575-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-20	2023-09-12

Product code IYE

K192196Class IIMedical Radiation Dosimetry System microSTARiiLandauer / cleared 2019-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)