Z-1804-2020 Class II
FDA device recall Z-1804-2020 was initiated by Boston Scientific Corporation on September 18, 2019 and is designated Class II. Reason for recall: 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 Diast… Affected quantity: 150 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- September 18, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 units
Product Description
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Reason for Recall
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.
Distribution Pattern
OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees.
Code Information
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.