Recalls / —
—#148762
Product
Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
- FDA product code
- CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K031560
- Affected lot / code info
- All Serial Numbers
Why it was recalled
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 (FDA determination)
Software design
Action the firm took
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
Recalling firm
- Firm
- Siemens Healthcare Diagnostics Inc
- Address
- 2 Edgewater Dr, Norwood, Massachusetts 02062-4637
Distribution
- Distribution pattern
- 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
Timeline
- Recall initiated
- 2016-08-11
- Terminated
- 2020-07-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #148762. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.