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Class 2 Device Recall IMRIS T2X 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-0645-2019 |
Recall Event ID |
81574 |
Product Classification |
Table, operating-room, ac-powered - Product Code FQO
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Product |
IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - 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)108000-000, Serial Numbers: 10000983, 10000652 (b)108000-600, Serial Numbers: 06-0025, 10001306 (c)109682-000, Serial Numbers: 10002375, 10001118, 10001340 (d)109682-600, Serial Numbers: 10001119, 10001188, 10003634, 05-002, 10003638, 10003623, 10001305 (e)110470-600, Serial Numbers: 10006887 |
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 |
15 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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