| Class 2 Device Recall IMRIS ORT 200, Removable Operating Room Table | |
Date Initiated by Firm | November 06, 2018 |
Create Date | December 20, 2018 |
Recall Status1 |
Terminated 3 on July 25, 2021 |
Recall Number | Z-0647-2019 |
Recall Event ID |
81574 |
Product Classification |
Table, operating-room, ac-powered - Product Code FQO
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Product | IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient. |
Code Information |
(a) 113821-000, Serial Numbers: 10002220 (b) 113821-600, Serial Numbers: 10002692, 10006152, 10007192, 10006991, 10003754, 10006997, 10004513 (c) 114148-000, Serial Numbers: 10004463, 10005190, 10005189, 10006891, 10004997 (d) 114148-600, Serial Numbers: 10006891 |
Recalling Firm/ Manufacturer |
Deerfield Imaging, Inc. 5101 Shady Oak Rd S Minnetonka MN 55343-4100
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For Additional Information Contact | 763-203-6300 |
Manufacturer Reason for Recall | Table may drift in the roll position while in use |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm initiated the recall by letter on 11/06/2018. The letter explained the issue, requested the consignee follow the recommended daily test in all positions until the roll cylinders are exchanged. |
Quantity in Commerce | 14 units |
Distribution | Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy. |
Total Product Life Cycle | TPLC Device Report |
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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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