Device Recall Laserworld 의 리콜

Recall

62624

Class 2

Z-1538-2013

2012-07-19

2013-09-19

Terminated

United States

2018-06-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111195

A potential lack of certification, and/or missing laser certification, laser safety warning and administrative labels, and potentially incomplete performance feature set and incomplete user information were discovered.

CDRH approves the CAP subject to the following conditions: 1. Laserworld shall expand the scope of the CAP to include all projectors distributed between 2008 and 20l2, including, but not limited to, the Proline Series AG, Revolution Series AG, Club Series AG, Club Series, Pure Light Series, and Revolution Series AG, and Laserworld will continue to evaluate whether these additional projector models have similar defects. 2. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 3. Laserworld will maintain records to document the number of projectors returned under the CAP, and will document the specific items of non-compliance addressed for each product tested, repaired, relabeled and/or replaced. 4. Laserworld will provide CDRH with quarterly status updates on the progress of the CAP. 5. The correction of the non-compliant products must be made at no cost to the customers. You may proceed with implementation of the CAP (subject to the conditions