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Class 2 Device Recall IMRIS ORT 300, Removable Operating Room Table |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
November 06, 2018 |
Create Date |
December 20, 2018 |
Recall Status1 |
Terminated 3 on July 25, 2021 |
Recall Number |
Z-0648-2019 |
Recall Event ID |
81574 |
Product Classification |
Table, operating-room, ac-powered - Product Code FQO
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Product |
IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - 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) 114093-000, Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10005612, 10004372, 10002841 10002255, 10002385, 10005613 (b) 114093-006, Serial Numbers: 10007411, 10002996, 10004515 |
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
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Manufacturer Reason for Recall |
Table may drift in the roll position while in use
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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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