CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report

Operating room table recalled by Deerfield Imaging

Deerfield Imaging is recalling Operating room table, distributed nationwide in the US. The recall was initiated on 25 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00857534006356 Model Number: 114093-000; Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10006737, 10004372, 10002841, 10005613, and 10002255.

Quantity recalled10 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2585-2021
FDA event ID: 88661
Recalling firm: Deerfield Imaging, Minnetonka, MN
Classification: Class II
Status: Terminated
Recall initiated: 25 Aug 2021
FDA classified: 28 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

25 Aug 2021	Recall initiated by company
28 Sep 2021	Classified by FDA	+34 days
6 Oct 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

Where it was distributed

Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.

Nationwide California Florida North Carolina New Hampshire Ohio Oregon Tennessee Texas Utah

Questions about this recall

Why was it recalled?

ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

Which lots are affected?

UDI: 00857534006356 Model Number: 114093-000; Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10006737, 10004372, 10002841, 10005613, and 10002255.

Where was it sold?

Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 88661

Reported	Class	Recall	Company	Reason	Where
6 Oct 2021	CLASS II	Operating room table recalled by Deerfield Imaging	Deerfield Imaging	Device Malfunction	Nationwide
6 Oct 2021	CLASS II	Operating room table recalled by Deerfield Imaging	Deerfield Imaging	Device Malfunction	Nationwide

More recalls from Deerfield Imaging

All 21

Reported	Class	Recall	Company	Reason	Where
20 Apr 2022Device	CLASS II	Trumpf Mount Clamp Assembly (table adapter component) recalled	Deerfield Imaging	Other	Nationwide
6 Oct 2021Device	CLASS II	Operating room table recalled by Deerfield Imaging	Deerfield Imaging	Device Malfunction	Nationwide
6 Oct 2021Device	CLASS II	Operating room table recalled by Deerfield Imaging	Deerfield Imaging	Device Malfunction	Nationwide
8 Jan 2020Device	CLASS II	iMRX MRI and Angiography System recalled by Deerfield Imaging	Deerfield Imaging	Device Malfunction	CT, MA, VA
30 Oct 2019Device	CLASS II	Imris MR/X-ray head fixation device recalled by Deerfield Imaging	Deerfield Imaging	Device Malfunction	FL, NH, TN

Other Surgical Instruments recalls

All 3,883

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy	Karl Storz Endoscopy	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled	ASP Global	Device Malfunction	Nationwide