FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics Inc: Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784
- Recall number
- Z-2798-2016
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Product
- Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784
- Status
- Terminated
- Initiated
- 2016-08-11
- Posted
- not on file
- Terminated
- 2020-07-16
- Reason
- There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
- Root cause
- Software design
- Action
- Siemens Healthcare issued Urgent Field Safety Notice to (US) customers via Federal Express. . All affected customers outside the US provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. This notice informs customers of the issue, Actions to be Taken by the Customer and to return the response form. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative
- Quantity
- 2910 units
- Distribution
- Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Ivory Coast Japan Kazakhstan Kenya Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia Malaysia Mexico Netherlands New Caledonia New Zealand Norway P.R. China Peru Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Romania Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan U.A.E. United Kingdom Uruguay Vatikancity Vietnam
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- ["K110277"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 3002637618
- Firm city
- Norwood
- Firm state
- MA
- 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