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U.S. Department of Health and Human Services

Class 2 Device Recall 89 North

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  Class 2 Device Recall 89 North see related information
Date Initiated by Firm January 31, 2020
Create Date August 25, 2020
Recall Status1 Terminated 3 on May 02, 2023
Recall Number Z-2820-2020
Recall Event ID 86158
Product Classification Research laser - Product Code REK
Product LDI Laser firmware lower than V02.13.00 for
LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6

Laser Science fluorescence imaging
Code Information LDl-7, LDI-WF, LDI-NIR, LDl-6
Recalling Firm/
Manufacturer		 89 NORTH
20 Winter Sport Ln
Williston VT 05495-8144
Manufacturer Reason
for Recall		 The defect relates to firmware version lower than V02.13.00. It is controlling safety interlocks of the LDI; specifically, the potential for the LDI to enter a service mode intended for use in the factory environment only which overrides all interlocks. When this mode - "Interlock Override Mode" - is entered, the system does not cease laser emission when interlocks are opened, but rather allows emission to continue with open interlocks. The potential for this to occur is non-compliant with 21CFR 1040 .10{f )(2) and 21 CFR 1040 .10(f)(3).
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action All customers who purchased an LOI prior to identification of the defect were notified of the defect electronically per the email address on record for each customer. Each affected LOI was identified by serial number per our production records. 2. The firmware upgrade was distributed to all affected customers via the electronic notification. A website link embedded in the electronic notification brings customers to an electronic form where they are asked to submit their contact information as well as the serial numbers of the LDI units they are upgrading. 3. Upon completing the form, the user is provided (via the form) another link which contains the firmware download as well as instructions for performing the upgrade. 4. For those customers who want assistance (as stated in the notification to customers), 89 North technical support can perform the upgrade for them via a remote session to the customer's computer which is interfaced to the LDI product. Please contact us with any questions or if you need any assistance completing the update and we would be happy to help you. Feel free to reach out to your normal 89 North support contact, or you can reach us at (802) 881-0302 (menu option 6) or ldi-fw-supoort@89north.com.
Quantity in Commerce 188
Distribution Worldwide
Total Product Life Cycle TPLC 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.
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