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U.S. Department of Health and Human Services

Class 2 Device Recall Synaptive ImageDrive Clinical

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  Class 2 Device Recall Synaptive ImageDrive Clinical see related information
Date Initiated by Firm February 26, 2020
Create Date April 22, 2020
Recall Status1 Terminated 3 on April 10, 2024
Recall Number Z-1759-2020
Recall Event ID 85216
510(K)Number K153284  
Product Classification System, image processing, radiological - Product Code LLZ
Product Synaptive ImageDrive Clinical
Code Information ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1
Recalling Firm/
Manufacturer		 Synaptive Medical Inc
555 Richmond St West, Suite 800
Toronto Canada
For Additional Information Contact Maham Ansari
647-243-3122
Manufacturer Reason
for Recall		 A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated this field corrective action by letter on 02/26/2020. The consignees are not required to discontinue using the device nor return the device to Synaptive Medical, a workaround is to be followed as indicated in the customer notification letter. The actions to be taken by consignees with the affected product are as follows: 1. Acknowledge receipt of the notification using the acknowledgment and receipt form that the firm has provided. 2. a) If ClearCanvas Workstation is NOT used for viewing images on removeable media such as CDs, and this issue is encountered, configure the PACS or DICOM device that is sending images to ClearCanvas Workstation to send uncompressed images, or images compressed with a compression algorithm other than JPEG 2000. b.) If ClearCanvas Workstation IS used for viewing images on removeable media such as CDs OR if it is not possible to change the sending device to send uncompressed images, contact Synaptives Product Support Recall Line at 1.866.853.8001 to request assistance to correct the device. Note that if the software is subsequently re-installed, the device will need to be corrected again. Contact Synaptive to repeat the correction.
Quantity in Commerce 28 units
Distribution US
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.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = SYNAPTIVE MEDICAL INC.
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