TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
Summary
The FDA issued a Class I for TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oxi by GE Healthcare Finland Oy. Reason: There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement..
Details
Source
Device Recall
External ID
Z-2027-2023
Action Date
2023-07-12
Status
Ongoing
Category
device
Product Description
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
Lot/Code Info: a) REF TS-AF-10, GTIN 0840682103176 b) REF TS-AF-25, GTIN 0840682103176
Quantity Affected: 36337 devices
Reason for Recall
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-19
Company
Helsinki, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 287 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Healthcare Finland Oy has 24 FDA actions in our database, including 19 recalls and 5 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (GE Healthcare Finland Oy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Healthcare Finland Oy have FDA actions?
GE Healthcare Finland Oy has 24 FDA actions in our database, including 19 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2027-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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