Data Foundry

Medical device recalls 2013

Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser… — Class II medical device recall Z-0516-2013

Terminated recall by Motorola Inc, reported 2013-02-06, distributed nationwide. It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device

Recall numberZ-0516-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMotorola Inc, Holtsville, NY, United States
Recall initiated2012-04-27
Classified2013-01-30
Reported by FDA2013-02-06
Terminated2018-06-29
DistributedNationwide (US)
Quantity16,961 units
Reason classeslabeling

Product

Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products

Reason for recall

It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0516-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.