Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the
FDA device recall Z-0211-2015 · posted 2014-11-13 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Reason for recall
- Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power
- Action taken
- Maquet Inc. sent a Product Recall Urgent Medicall Device Field Correction letter to all of their customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter stated that a software upgrade will be performed by an authorized Maquet Service Technician. A Maquet representative will contact customer to schedule an on-site service of the device. Any questions can be directed to the local Maquet representative or Maquet Customer Service at 1-888-627-8383 (option 2, option 2) Monday through Friday, between the hours of 8:00 am and 6:00 pm (EST).
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 331 units
- Distribution
- Worldwide Distribution - US Nationwide
- Date initiated
- 2014-10-17
- Date posted
- 2014-11-13
- Date terminated
- 2016-04-06
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOHELP SYSTEM (K102726) | Maquet Cardiopulmonary, AG | 2011-04-04 |