epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, C
Summary
The FDA issued a Class II for epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc by Siemens Healthcare Diagnostics Inc. Reason: pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure.
Details
Source
Device Recall
External ID
Z-1214-2023
Action Date
2023-03-15
Status
Ongoing
Category
device
Product Description
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 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604
Lot/Code Info: Host Software Version /Sensor Configuration: 3.37.3/41.1 Product Description Siemens Material Number (SMN) Unique Device Identification (UDI-DI) epoc Host 2 10736387 00809708052898; epoc Host 2, Canada 10736388 00809708069117; epoc Host 2, China 10736389 00809708097219; epoc Host 2, Japan 10736390 00809708075576; epoc Host 2, Refurbished 10736393 00809708053901; epoc Host 2, Canada, Refurbished 10736394 00809708069124; epoc Host 2, Japanese, Refurbished 10736395 00809708075583; epoc Host 2, Chinese, Refurbished 10736433 00809708097226; epoc Host 2, US (MC55X) 11413524 00630414606460; epoc Host 2, ROW (MC55X) 11413528 00630414606378; epoc Host 2, India (MC55X) 11413541 00630414608617; epoc Host 2, China (MC55X) 11413542 00630414608624; epoc Host 2, Japan (MC55X) 11413543 00630414608532; epoc Host 2 (MC55X) - US - Refurbished 11413601 00630414615004; "epoc Host 2 (MC55X) - ROW - Refurbished" 11413602 00630414614885; epoc Host 2 (MC55X) - India - Refurbished 1413603 00630414614762; epoc Host 2 (MC55X) - Japan - Refurbished 11413604 00630414614892.
Quantity Affected: 22,156 units
Reason for Recall
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Distribution
Nationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kuwait Laos Latvia Lithuania Luxembourg Malaysia Mali Martinique Mexico Myanmar Netherlands New Caledonia New Zealand Norway Papua Nw Guinea Peru Philippines Poland Portugal Qatar Republic Korea Reunion Romania Russian Fed. San Marino Singapore Slovakia Slovenia Solomon Islands South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey U.A.E. Ukraine United Kingdom Uruguay Vietnam
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-12
Company
Norwood, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics Inc has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics Inc have FDA actions?
Siemens Healthcare Diagnostics Inc has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1214-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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