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U.S. Department of Health and Human Services

Class 2 Device Recall IMRIS ORT 200, Removable Operating Room Table

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  Class 2 Device Recall IMRIS ORT 200, Removable Operating Room Table see related information
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
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
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
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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