FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
- Recall number
- Z-2015-2012
- Recalling firm
- GE Healthcare, LLC
- Product
- GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
- Status
- Terminated
- Initiated
- 2012-06-12
- Posted
- 2012-07-16
- Terminated
- 2013-12-05
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Product ID Number Lot Code 2016995-001 xxxx2010E 2016995-002 xxxx2010D 2016995-003 xxxx2010C 2016995-004 xxxx2010C
- 510(k) numbers
- ["K042642"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28