Z-1032-2016 Class II Terminated
FDA device recall Z-1032-2016 was initiated by Novadaq Technologies Inc. on January 29, 2016 and is designated Class II. Reason for recall: It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the rep… The recall status is terminated (terminated November 3, 2016). Affected quantity: 110 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2016
- Initiation Date
- January 29, 2016
- Termination Date
- November 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 units
Product Description
PINPOINT Endoscopic Fluorescence Imaging System
Reason for Recall
It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.
Distribution Pattern
Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.
Code Information
Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000