Reported Jul 12, 2023 · Ongoing
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
GE Healthcare Finland Oy
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare Finland Oy · Kuortaneenkatu 2 · Helsinki, N/A · N/A
Is this the product you have?
- TruSignal AllFit Sensor
a) REF TS-AF-1010 pcsB) REF AF-2525 pcsOximeter
- Lot codes and dates
a) REF TS-AF-10GTIN 0840682103176 b) REF TS-AF-25GTIN 0840682103176
- Amount recalled
- 36337 devices
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
Stop using this product now
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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