iLab Polaris Multi-Modality Guidance System recall: Software Issue
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Why was iLab Polaris Multi-Modality Guidance System recalled?
Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended. If either Multi-Frame UltraSound (US) or SC Image Storage formats are used, the DFR data will not be archived and the user will not be notified of this unexpected behavior.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Polaris 2.10 software version (disk batch 629774); iLab Polaris Systems affected product listing (serial numbers): 200204, 200209, 200217, 200308, 200310, 200448, 200450, 200456, 200457, 200458, 200461,200480, 200481, 200103, 200145, 200044, 200118, 200360, 200498, 200170, 8361, 10312, 10443, 10548, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278,10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278, 10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278, 10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 6582 , 7023, 7857, 5637, 5716, 6650, 6894, 4031, 5003, 5043, 5060, 5109, 5232, 5239, 5393, 5465, 5651, 5678, 5860, 6193, 6350, 8264, 6819, 6921, 6934, 7332, 7341, 7362, 7733, 7828, 7858, 7933, 7934, 8011, 8155, 8290, 6383, 5182, 5219, 5296, 5398, 8157, 6760, 7723, 10108, 8365, 8367, 10504, 10657, 10501, 4274, 8046, 8048, 5892, 7818, 4773, 5585, 8113, 5165, 4402, 6468, 6319, 5313, 7511, 4952, 5277, 5457, 4116, 5403, 5078, 5664, 5666, 6327, 6733, 6994, 6136, 6206, 6172, 7604, 7602, 7353, 6273, 6993, 4045, 10221, 10261, and 8540.
- Product
- iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 150 units
- Distribution
- OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees.
- Recall date
- May 6, 2020
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)