Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081
FDA device recall Z-0924-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medtronic Gastroenterology / Urology
- Reason for recall
- Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.
- Action taken
- 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
- Status
- Terminated
- Product code
- FFX
- Quantity affected
- 42 units
- Distribution
- The devices were distributed nationwide in the United States.
- Date initiated
- 2004-04-28
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-21
- Location
- Shoreview, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 (K981733) | Medtronic Functional Diagnostics A/S | 1999-02-04 |