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U.S. Department of Health and Human Services

Class 2 Device Recall Endoscope Video Imaging System

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 Class 2 Device Recall Endoscope Video Imaging Systemsee related information
Date Initiated by FirmJanuary 29, 2016
Create DateMarch 02, 2016
Recall Status1 Terminated 3 on November 03, 2016
Recall NumberZ-1032-2016
Recall Event ID 73225
510(K)NumberK091515 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductPINPOINT Endoscopic Fluorescence Imaging System
Code Information Rev. J, Rev. K, Rev. L and Rev. M  Model Number : PC9000
Recalling Firm/
Manufacturer		 Novadaq Technologies Inc.
8329 Eastlake Dr Unit 101
Burnaby Canada
For Additional Information ContactJen Pendlebury
905-629-3822 Ext. 205
Manufacturer 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.
FDA Determined
Cause 2		Process design
ActionNovadaq sent an Urgent Device Correction letter dated February 2, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recipients of this notice have received shipments that include the inaccurate Operator's Manual. Please follow these instructions: 1. Discard any old PINPOINT Operator's Manuals Rev J through M. 2. Accept and review the new PINPOINT Operator's Manual (Rev N). 3. Complete and sign the enclosed "Acknowledgement of Receipt" form, scan it and email to PI NPOINT@novadaq.com. Any questions or concerns may also be sent to this address. For further questions, please call 1-(844) 668-2327, ( Select Option # 1)
Quantity in Commerce110 units
DistributionWorldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GCJ
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