Z-0647-2019Class II

IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000...

Name: Z-0647-2019 IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000...
Creator: Deerfield Imaging, Inc.
Published: 2018-11-06
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2018-11-06 / Terminated

FDA source

Deerfield Imaging, Inc. began a recall of IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and... on 2018-11-06. FDA classified it as Class II and gives the reason as "Table may drift in the roll position while in use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0647-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-06
Posted: 2018-12-20
Terminated: 2021-07-25
Recalling firm: IMRIS Imaging, Inc.
Product: IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: Table may drift in the roll position while in use
FDA root cause: Under Investigation by firm
Action: The firm initiated the recall by letter on 11/06/2018. The letter explained the issue, requested the consignee follow the recommended daily test in all positions until the roll cylinders are exchanged.
Quantity in commerce: 14 units
Distribution: Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.
Product codes and lots: (a) 113821-000, Serial Numbers: 10002220 (b) 113821-600, Serial Numbers: 10002692, 10006152, 10007192, 10006991, 10003754, 10006997, 10004513 (c) 114148-000, Serial Numbers: 10004463, 10005190, 10005189, 10006891, 10004997 (d) 114148-600, Serial Numbers: 10006891

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0647-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0645-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20
Z-0646-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20
Z-0647-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20
Z-0648-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20

Product code FQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)