Who else makes this device?

Name: ORT200
Brand: ORT200

ORT200 · Table, Operating-Room, Ac-Powered → General & Plastic Surgery

11manufacturers in China registered for this device type

1catalogue number

13recalls on this code

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (1), Anhui (1).

Chinese manufacturers registered for FDA product code FQO
Manufacturer	City	Province	Registered as	Device types
Jiangsu Saikang Medical Equipment Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	34
Jiangsu Yongfa Medical Equipment Technology Co., Ltd.	Zhangjiagang	Jiangsu	Manufacturer	33
Shanghai NO. 2 Medical College Duhang Medical Equipment Factory	Shanghai	Shanghai	Contract manufacturer	32
Jiangsu Rooe Medical Technology Co., Ltd.	Zhangjiagang	Jiangsu	Manufacturer	31
Hefei MT Medical Co., Ltd.	Hefei	Anhui	Manufacturer	23
Jiangsu Keling Medical Appliances Co., Ltd.	Yangzhou	Jiangsu	Contract manufacturer	23
Hebei Jiede Medical Equipment Co., Ltd.	Hengshui	Hebei	Contract manufacturer	20
Suzhou Number WIN Medical Technology Co., Ltd.	Zhangjiagang	Jiangsu	Manufacturer	16
Shandong Deman Medical Equipment Group Co., Ltd.	Jining	Shandong	Manufacturer	11
Nanchang Micare Medical Equipment Co., Ltd.	Nanchang	Jiangxi	Manufacturer	8
Nanjing Mindray BIO-Medical Electronics Co., Ltd.	Nanjing	Jiangsu	Manufacturer	2

Record

Regulatory record for ORT200
Listed by	Imris Imaging, Inc., United States
FDA product code	FQO
Device type	Table, Operating-Room, Ac-Powered
Device class	Class 1
Regulation	21 CFR 878.4960
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2024-10-04
Record revised	2025-04-08 (version 2)

Specifications

Specifications
MRI safety	MR Conditional
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for ORT200
Catalogue number	Size	Status
113821-000		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
HarmonyAIR	Steris Corporation	452
Skytron	Skytron, LLC	200
Table, Operating-Room, Ac-Powered	Steris Corporation	165
iCE boom and Pendant	Amico Clinical Solutions	102
Mindray	Nanjing Mindray BIO-Medical Electronics Co., Ltd.	95
Amtai	Amtai Medical Equipment, Inc.	95
Steris	Steris Corporation	72
Alyon	Steris Corporation	41
Foot switch	Maquet Gmbh	23
Amsco	Steris Corporation	14
Atec A.R.M.	Alphatec Spine, Inc.	13
Universal table top	Maquet Gmbh	13

Showing 12 of 442. All products under Table, Operating-Room, Ac-Powered

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of ORT200
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Imris Imaging, Inc.	UDI-DI	2021-08-25	Class II	Device Design	ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.	13 units	2024-04-30

Recalls

13 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2026-08-06	Class II	Nonconforming Material/Component	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 rota	6 units
2018-11-06	Class II	Under Investigation by firm	Table may drift in the roll position while in use	14 units	2021-07-25
2018-11-06	Class II	Under Investigation by firm	Table may drift in the roll position while in use	14 units	2021-07-25
2018-11-06	Class II	Under Investigation by firm	Table may drift in the roll position while in use	15 units	2021-07-25
2018-11-06	Class II	Under Investigation by firm	Table may drift in the roll position while in use	27 units	2021-07-25
2018-02-23	Class II	Under Investigation by firm	The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.	17 units	2019-08-27
2018-02-23	Class II	Under Investigation by firm	The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.	13 units	2019-08-27
2018-02-23	Class II	Other	The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.	17 units	2019-09-12
2018-02-23	Class II	Other	The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.	14 units	2019-09-12
2018-02-23	Class II	Other	The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.	26 units	2019-09-12
2018-02-23	Class II	Other	The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.	13 units	2019-09-12
2018-02-20	Class II	Device Design	The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.	16 tables	2019-08-27
2014-10-01	Class II	Use error	One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.	14	2015-02-20

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

ORT200