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
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2585-2021 |
| Event ID | 88661 |
| Event Description | Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan. |
| Quantity | 10 units |
| Recall Reason | ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. |
| Device Classification | 20211006 |
| Device Code Info | UDI: 00857534006356 Model Number: 114093-000; Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10006737, 10004372, 10002841, 10005613, and 10002255. |
| Center Classification Date | 20210928 |
| Recall Initiation Date | 20210825 |
| Recalling Firm | Deerfield Imaging, Inc. |
| Initial Notification | Letter |
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