medical Class II Updated 2018-12-26

Deerfield Imaging, Inc. recalls IMRIS ORT 300, Removable Operating Room Table, Part Numbers:

Recalled Product

IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - 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.


Hazard / Issue

Table may drift in the roll position while in use

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: (a) 114093-000, Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10005612, 10004372, 10002841 10002255, 10002385, 10005613 (b) 114093-006, Serial Numbers: 10007411, 10002996, 10004515
View official government recall

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