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Health product recall

RAPIDPoint Blood Gas Analyzers (2016-08-12)

Starting date:
August 12, 2016
Posting date:
August 26, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-59984

Affected Products

  1. RAPIDPoint 400 Blood Gas Analyzer
  2. RAPIDPoint 405 Blood Gas Analyzer
  3. RAPIDPoint 1260 Blood Gas Analyzer
  4. RAPIDPoint 1265 Blood Gas Analyzer
  5. RAPIDPoint 500 Blood Gas Analyzer

Reason

Siemens Healthcare Diagnostics has determined that when certain steps occur 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.

Affected products

A. RAPIDPoint 400 Blood Gas Analyzer

Lot or serial number
  • 10291507
  • 10314585
  • 10318899
  • 10321239
  • 10322654
  • 10324081
  • 10328803
  • 10331381
  • 10339634
Model or catalog number

106444

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES

B. RAPIDPoint 405 Blood Gas Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 05320281
  • 129887
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
62 Flanders-Bartley Road
Flanders,
07836
New Jersey
UNITED STATES

C. RAPIDPoint 1260 Blood Gas Analyzer

Lot or serial number
  • 10321840
  • 10491392
Model or catalog number

1240

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES

D. RAPIDPoint 1265 Blood Gas Analyzer

Lot or serial number
  • 10321852
  • 10470366
  • 10491395
Model or catalog number

1265

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES

E. RAPIDPoint 500 Blood Gas Analyzer

Lot or serial number
  • 10492730
  • 10696855
  • 10696857
  • 10697306
Model or catalog number

10492730

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES

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