Home / Recalls / Deerfield Imaging, Inc. / Z-0646-2019

Z-0646-2019 Class II Terminated

Recalled by Deerfield Imaging, Inc. — Minnetonka, MN

Recall Details

Product Type
Devices
Report Date
December 26, 2018
Initiation Date
November 6, 2018
Termination Date
July 25, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27 units

Product Description

IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - 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.

Reason for Recall

Table may drift in the roll position while in use

Distribution Pattern

Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.

Code Information

(a) 110470-000, Serial Numbers: 10002845, 10002341, 10003629, 10003801, 10003830, 10002847, 10002796, 10003243, 10002654, 10003841, 10002607, 10007348, 10007424, 10005651, 10004250, 10004439, 10003241, 10006886, 10002848, 10006438, 10003007, 10004576, 10003245 (b) 110470-600, Serial Numbers: 10003244, 10003064, 10003244, 10002343

Other recalls by Deerfield Imaging, Inc.

  • Z-0934-2022 Class II — Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a compo (February 17, 2022)
  • Z-2584-2021 Class II — Operating room table - Product Usage: intended for use during diagnostic examina (August 25, 2021)
  • Z-2585-2021 Class II — Operating room table - Product Usage: intended for use during diagnostic examina (August 25, 2021)
  • Z-2586-2021 Class II — Operating room table - Product Usage: intended for use during diagnostic examina (August 25, 2021)
  • Z-0762-2020 Class II — iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/i (November 26, 2019)
  • Z-0163-2020 Class II — IMRIS MR/X-ray head fixation device, Model HFD200 (June 26, 2019)
  • Z-0645-2019 Class II — IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) (November 6, 2018)
  • Z-0648-2019 Class II — IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b (November 6, 2018)
  • Z-0647-2019 Class II — IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b (November 6, 2018)
  • Z-1645-2018 Class II — IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI (April 4, 2018)