Z-2015-2012Class II

GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003...

Name: Z-2015-2012 GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003...
Creator: GE Healthcare, LLC
Published: 2012-06-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-06-12 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004 on 2012-06-12. FDA classified it as Class II and gives the reason as "GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect...". 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-2015-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-12
Posted: 2012-07-16
Terminated: 2013-12-05
Recalling firm: GE Healthcare
Product: GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect O-ring, the mating of the cable with the transducer is faulty. This situation inhibits blood pressure measurement from being monitored correctly.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: GE Healthcare sent a Urgent Medical Device Correction letter dated June 12, 2012, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Inforamtion. Advised customers to discontinue use, further distribution and to contact their customers. Please return any defective Invasive Blood Pressure Cables by isolating all affected product and completing the attached Confirmation form/fax back per its instructions. This step is required to confirm receipt of communications with all customers. If you have any questions or concerns regarding this notification, please contact Customer Service at +1-800-932-0760 (Domestic & International). Hours of Operation: 8:00 am EST to 6:00 pm EST. .
Quantity in commerce: 279
Distribution: Worldwide Distribution -- USA (nationwide) including the states of AK, CA, IL, MS, NJ, PR, SD, TN, TX, and VA. and the countries of ARGENTIAN, AUSTRALIA, BELGIUM, CHINA, GERMANY, ALGERIA, ECUADOR, EGYPT, FINLAND, UNITED KINGDOM, JORDAN, JAPAN, MOROCCO, MAURITUS, NETHERLANDS, OMAN, PERU, SEBIA, SUDI ARABIA, SINGAPORE, EL SALVADOR, TURKEY, URUGUAY and SOUTH AFRICA.
Product codes and lots: Product ID Number Lot Code 2016995-001 xxxx2010E 2016995-002 xxxx2010D 2016995-003 xxxx2010C 2016995-004 xxxx2010C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2015-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2015-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-16

Product code MHX

K042642Class IIAware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor)Ge Medical Systems Information Technologies / cleared 2004-11-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)