Class 2 Medicines : Norgine Pharmaceuticals Limited, Pedmarqsi 80
OFFICIAL-SOURCE RECALL · UNITED KINGDOM
Radiofrequency (RF) Safety Considerations for Wireless Recall: The MHRA has conducted a review into the use
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CountryUnited KingdomPublishedSeptember 17, 2026Last updatedSeptember 17, 2026Official source last checkedSeptember 17, 2026 at 1:03 PM UTC
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Radiofrequency (RF) Safety Considerations for Wireless Cardiotocography (CTG) Monitoring Systems (DSI/2026/012)
- Manufacturer
- See official notice
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
The MHRA has conducted a review into the use of wireless cardiotocography (CTG) systems that use radiofrequency (RF) telemetry channels. Signal crossover, erroneous CTG traces and signal dropouts have been identified as patient safety risks associated with these devices.
Hazard
The MHRA has conducted a review into the use of wireless cardiotocography (CTG) systems that use radiofrequency (RF) telemetry channels. Signal crossover, erroneous CTG traces and signal dropouts have been identified as patient safety risks associated with these devices.
What consumers should do
s for Healthcare Professionals including Clinical and Medical equipment management staff: ensure that two or more wireless CTG devices are not operating on the same RF channel unless there is sufficient distance between them to prevent signal crossover or interference (see under Operational Controls in the Actions for NHS Organisations section for further details). For example, in the absence of any obstacles such as walls or pillars, a distance of 100 metres may be required between two devices operating on the same RF channel to avoid signal crossover. Note that the wall between adjacent rooms may not be sufficient to prevent signal crossover. There is also the potential for signal crossover between floors. The Instructions for Use and/or manufacturer guidance should be consulted for device-specific advice on this matter verify CTG traces clinically at the commencement and throughout the period of monitoring. Ensure CTG traces correlate with other clinical features such as: maternal pulse; clinical assessment of fetal and maternal condition; verification that displayed FHR belongs to the correct patient ensure access to a wired CTG system as a backup in the event of signal drop ou
Official recall notice
Radiofrequency (RF) Safety Considerations for Wireless Cardiotocography (CTG) Monitoring Systems (DSI/2026/012)
Agency: Medicines and Healthcare products Regulatory Agency
Official publication date: September 17, 2026
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