Cervical Extension Machine for Physical Therapy
FDA Recall Z-0936-2015 · Posted 2015-01-07
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Recalling FirmMedX Holdings, Inc.
Recall StatusTerminated
Product CodeIKK
Date Initiated2013-12-03
Date Terminated2016-09-29
Product Quantity4
Reason for Recall
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Firm Action
Medx began contacting its consignees December 30, 2013, to schedule testing on the devices at their facility. The technician has been scheduled to complete required testing of these devices in the field.
For questions regarding this recall call 322-351-2005.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.
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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