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Terminated

IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw

FDA Recall Z-3211-2017 · Posted None

Recalling FirmDeerfield Imaging
Recall StatusTerminated
Product CodeHBL
Date Initiated2017-08-14
Date Terminated2018-05-29
Product Quantity6 screws

Reason for Recall

incorrect thread on thumbscrews

Firm Action

The firm notified the consignees by email on 08/14/2017. The letter stated that the screws would be replaced.

Root Cause

Process control

Distribution Pattern

IL, OR, PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103493HEAD FIATION DEVICE (HFD 100)Imris, Inc. · 2011-03-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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