ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the
Summary
The FDA issued a Class II for ORT200, operating room table, including the ORT200 Covered Table Assembly, Recon by IMRIS Imaging Inc. Reason: The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between l.
Details
Source
Device Recall
External ID
Z-3033-2026
Action Date
2026-09-02
Status
Ongoing
Category
device
Product Description
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
Lot/Code Info: 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997
Quantity Affected: 6 units
Reason for Recall
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-06
Company
Chaska, 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 168 device recalls issued in the same week, part of 445 device-related FDA actions this month.
IMRIS Imaging Inc has 4 FDA actions in our database, including 3 recalls and 1 clearance.
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 (IMRIS 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 IMRIS Imaging Inc have FDA actions?
IMRIS Imaging Inc has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3033-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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