Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-809, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.
FDA Recall Z-1614-2008 · Posted 2008-05-21
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Recalling FirmMed Tec Inc dba CIVCO Medical Solutions
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-02-28
Date Terminated2008-07-02
Product Quantity33/3-marker pouches
Reason for Recall
Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers.
Firm Action
Consignees were notified via telephone beginning 2/28/08 and a Recall Notification letter sent on 2/29/08. Users were requested to return any affected products for a replacement. They were also requested to return a recall notification form indicating the amount of affected product in their inventory. For additional information, call 800-842-8688.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution including states of WA, PA, DE, AL, CT, WI, FL, TX, MN, and IL.
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.
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