Food, drugs, devices › Deerfield Imaging, Inc.
Device recall: Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical
Deerfield Imaging, Inc. (Minnetonka, MN) initiated this device recall on 25 Aug 2021; FDA lists 3 product records under event 88661, classified Class II.
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. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 30 Apr 2024. Initiation: voluntary: firm initiated. Deerfield Imaging, Inc. has 9 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
Deerfield Imaging, Inc., Minnetonka, MN.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2584-2021 | Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient. | 13 units | Class II | Terminated | 6 Oct 2021 |
| Z-2585-2021 | Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient. | 10 units | Class II | Terminated | 6 Oct 2021 |
| Z-2586-2021 | Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient. | 3 units | Class II | Terminated | 6 Oct 2021 |
Context
Other enforcement events for Deerfield Imaging, Inc.
All 9 events for Deerfield Imaging, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue."
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 distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Apr 2024. "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.