Product Safety Recalls

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Deerfield Imaging, Inc. Recall 88661

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

Deerfield Imaging, Inc. Recall 88661 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2584-2021
Event ID88661
Event DescriptionOperating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
Quantity13 units
Recall ReasonORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
Device Classification20211006
Device Code InfoUDI: 00857534006738 and 00857534006349 Model Number: 113821-000 (Serial Number: 10002220); Model Number: 113821-600 (Serial Numbers: 10002692, 10006152, 10006991, 10004513, 10006997, and 10003754); Model Number: 114148-000 (Serial Numbers: 10004463, 10006891, 10005189, 10005190, 10004327, and 10004997)
Center Classification Date20210928
Recall Initiation Date20210825
Recalling FirmDeerfield Imaging, Inc.
Initial Notification Letter
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