Device recall: ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the
FDA enforcement event 99596 is a device recall by IMRIS Imaging Inc of Chaska, MN, initiated 6 Aug 2026 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. IMRIS Imaging Inc has 2 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
IMRIS Imaging Inc, Chaska, MN.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3033-2026 | 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 | 6 units | Class II | Ongoing | 2 Sep 2026 |
| Z-3034-2026 | ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600 | 13 units | Class II | Ongoing | 2 Sep 2026 |
Context
Other enforcement events for IMRIS Imaging Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Dec 2025 | Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 1 (98132) | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.