Z-1577-2016Class I

Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number...

Name: Z-1577-2016 Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number...
Creator: Medtronic
Published: 2016-04-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-04-13 / Terminated

FDA source

Medtronic began a recall of Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the... on 2016-04-13. FDA classified it as Class I and gives the reason as "Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1577-2016
Classification: Class I
Status: Terminated
Initiated: 2016-04-13
Posted: 2016-05-12
Terminated: 2017-10-17
Recalling firm: Medtronic, Inc.
Product: Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack powers the monitor when AC power is not available or when monitoring is required during intra-hospital transfer of patients. The Capnostream"20 and Capnostream"20p is a combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital transport environments
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor.
FDA root cause: Process change control
Action: Medtronic sent an Urgent Medical Device Recall letter dated April 2016, by postal mail or courier to all affected customers. The letter instructed users to remove and properly dispose of current batteries. If product was further distributed customers were instructed to forward the recall letter. Customers were asked to completed and return the Acknowledgement and Receipt Form by fax or email. Customers with questions should contact Technical Services at 800-635-5267, option 1, ten 1 and 1 or by email at [email protected]. For questions regarding this recall call 303-876-8859.
Quantity in commerce: 9,817 batteries (8,170 with monitors and 1,647 as spare parts)
Distribution: Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Product was also distributed worldwide. There is 1 VA customer.
Product codes and lots: Product # 016400; All SNs, irrespective of production date. Product # 010520; All SNs with production date starting 14.14

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1577-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1577-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-12

Product code CCK

K123690Class IICapnostream20p with Hifi C02 MonitoringOridion Medical 1987 , Ltd. / cleared 2014-08-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)