83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
FDA Recall Z-0770-2007 · Posted 2007-05-04
Recalling FirmCustom Ultrasonics, Inc.
Recall StatusTerminated
Product CodeFEB
Date Initiated2005-12-12
Date Terminated2013-02-20
Product Quantity4 units
Reason for Recall
The device was marketed without a 510k
Firm Action
On 12/12/05, the recalling firm telephoned their sales representatives to inform them of the problem. Letter were hand delivered to the hospitals by the sales representatives.
Root Cause
PMA
Distribution Pattern
Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.