Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical
Summary
The FDA issued a Class II for Operating room table - Product Usage: intended for use during diagnostic examina by Deerfield Imaging, Inc.. Reason: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue..
Details
Source
Device Recall
External ID
Z-2585-2021
Action Date
2021-10-06
Status
Terminated
Category
device
Product Description
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Lot/Code Info: UDI: 00857534006356 Model Number: 114093-000; Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10006737, 10004372, 10002841, 10005613, and 10002255.
Quantity Affected: 10 units
Reason for Recall
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
Distribution
Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-25
Company
Minnetonka, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Deerfield Imaging, Inc. has 6 FDA actions in our database, including 4 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Deerfield Imaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Deerfield Imaging, Inc. have FDA actions?
Deerfield Imaging, Inc. has 6 FDA actions in our database, including 4 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2585-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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