Siemens epoc Host 2 blood gas analyzer recalled for pO2 measurement quality control issue
Siemens is recalling 22,156 units of the epoc Host 2 blood gas analyzer due to pO2 measurement quality control issues related to barometric pressure. The devices are distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall for measurement quality control issues on critical care blood gas analyzers. A pO2 measurement inaccuracy represents a risk-of-harm scenario where incorrect readings could guide inappropriate patient treatment decisions.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 22,156 units of the epoc Host 2 blood gas analyzer. The FDA classified this as a Class II recall.
The devices are affected by a quality control issue with pO2 (partial pressure of oxygen) measurements when adjusted for barometric pressure. The affected units operate on software version 3.37.3 with sensor configuration 41.1. Impacted variants include units distributed in the United States, Canada, China, India, Japan, and numerous other countries, including both new and refurbished models.
For further information or remediation instructions, users should contact Siemens or refer to the FDA recall notice.
The recalled product
- Product
- epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- pO2-measurement-error
- quality-control-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- epoc Host 2
- Canada 10736388 00809708069117
- China 10736389 00809708097219
- Japan 10736390 00809708075576
- Refurbished 10736393 00809708053901
- Canada
- Refurbished 10736394 00809708069124
- Japanese
- Refurbished 10736395 00809708075583
- Chinese
- Refurbished 10736433 00809708097226
- US (MC55X) 11413524 00630414606460
- ROW (MC55X) 11413528 00630414606378
- India (MC55X) 11413541 00630414608617
- China (MC55X) 11413542 00630414608624
- Japan (MC55X) 11413543 00630414608532
- epoc Host 2 (MC55X) - US - Refurbished 11413601 00630414615004
- epoc Host 2 (MC55X) - India - Refurbished 1413603 00630414614762
- epoc Host 2 (MC55X) - Japan - Refurbished 11413604 00630414614892.
Distribution
Distributed nationwide across the United States.
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