GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE M
FDA device recall Z-1132-2007 · posted 2007-08-07 · Terminated
Recall details
- Recalling firm
- General Electric Medical Systems Information Technology
- Reason for recall
- GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows.
- Action taken
- Consignees were sent a letter dated 2/16/07. The letter described the product and problem, made recommendations and gave information on software update.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 1513 (1067 US and 446 OUS)
- Distribution
- Worldwide, including USA, Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Israel
- Date initiated
- 2007-02-16
- Date posted
- 2007-08-07
- Date terminated
- 2011-12-11
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM (K050093) | Ge Medical Systems Information Technologies | 2005-05-13 |