Linear Array Transducer Type: 8809
FDA Recall Z-0271-05 · Posted 2004-12-02
Recalling FirmB & K Medical Systems Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2004-11-12
Date Terminated2005-01-18
Product Quantity17 units
Reason for Recall
Defect at probe tip may effect sterilization and electrical safety
Firm Action
BK Medical Wilmington, MA notified accounts by letter dated 11/ 12 /04 via UPS Overnight.. Accounts are requested to return the unit.
Root Cause
Other
Distribution Pattern
CA, CO, CT, FL, LA, GA, NJ, NY, VA, VT
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.