MAC-LAB 1000EX systems
FDA device recall Z-0783-03 · posted 2003-04-25 · Terminated
Recall details
- Recalling firm
- General Electric Medical Systems Information Technology
- Reason for recall
- There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
- Action taken
- A letter was sent to the consignees on April 14, 2003 and requested that the consignees correct the device or contact the firm to have them perform the correction.
- Root cause
- Other
- Status
- Terminated
- Product code
- KMI
- Distribution
- The recalled products were shipped to hospitals located nationwide in the United States and to other consignees located worldwide.
- Date initiated
- 2003-04-14
- Date posted
- 2003-04-25
- Date terminated
- 2004-06-24
- Location
- Milwaukee, WI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAC-LAB/CARDIOLAB EP/COMBOLAB (K021366) | General Electric Medical Systems Information Techn | 2002-07-03 |