FDA Device recall Z-1032-2016
PINPOINT Endoscopic Fluorescence Imaging System
- FDA Device
- Class II
- terminated
- Published 2016-03-09
On 2016-03-09 the FDA classified a Class II recall of PINPOINT Endoscopic Fluorescence Imaging System by Novadaq Technologies, citing 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 g….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1032-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-29 |
| Published | 2016-03-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Novadaq Technologies |
| Distribution | US |
Product
PINPOINT Endoscopic Fluorescence Imaging System
Reason
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.
Identifiers
| code_info | Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1032-2016%22
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