Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia
FDA device recall Z-0848-2014 · posted 2014-01-28 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Reason for recall
- Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.
- Action taken
- Maquet sent a product recall urgent-medical device field correction letter/customer fax response via Fed Ex on December 5, 2013, to their customers. Customers are advised of the issues with the device and provided instructions. The correction will include an update with replacement of the affected connector and if needed replacement of the thermoelectric cooler if it damaged. These operations will be performed by an authorized Maquet representative. Any questions can be directed to customer service at 1-888-627-8383 option 2 followed by option 3 Monday through Friday between the hours of 8 am and 6 pm EST. Customers should completed and return the enclosed confirmation form or scan a copy to field actions@maquet.com or fax (973) 807-9290.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- BTI
- Quantity affected
- 237 units
- Distribution
- Worldwide Distribution US, Canada and Japan.
- Date initiated
- 2013-12-05
- Date posted
- 2014-01-28
- Date terminated
- 2015-02-05
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E (K023354) | Siemens Elema AB | 2003-09-05 |