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Terminated

Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081

FDA Recall Z-0924-04 · Posted 2004-07-20

Recalling FirmMedtronic Gastroenterology / Urology
Recall StatusTerminated
Product CodeFFX
Date Initiated2004-04-28
Date Terminated2005-11-21
Product Quantity42 units

Reason for Recall

Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.

Firm Action

Letters dated April 28, 2004 were sent to the consignees. Enclosed with the letter to each consignee were replacement power cord(s). The letters instruct consignees to replace the current power cord by following instructions enclosed with the letter.

Root Cause

Other

Distribution Pattern

The devices were distributed nationwide in the United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981733DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111Medtronic Functional Diagnostics A/S · 1999-02-04

Official Source

View FDA Recall →

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

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