Z-0848-2014Class II

Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or...

Name: Z-0848-2014 Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2013-12-05
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2013-12-05 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of... on 2013-12-05. FDA classified it as Class II and gives the reason as "Maquet Compressor Mini may deliver compressed air at a temperature higher than specified". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0848-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-05
Posted: 2014-01-28
Terminated: 2015-02-05
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.
Product code: BTI Compressor, Air, Portable
Reason for recall: Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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 [email protected] or fax (973) 807-9290.
Quantity in commerce: 237 units
Distribution: Worldwide Distribution US, Canada and Japan.
Product codes and lots: Part number 6481779

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0848-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0848-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-28

Product code BTI

K023354Class IICompressor Mini, 115 V, Model 64 81 779 Eh81eSiemens Elema AB / cleared 2003-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)