The recent news that RRR Manufacturing Pty Ltd, supplier of the CellAED, has gone into liquidation – with the TGA publishing a Critical Recall notice in Australia – marks a sobering moment for our industry. The device had already been withdrawn from the UK market, with the MHRA issuing a Field Safety Notice in November 2024.
For those unfamiliar, CellAED was a compact, low-cost, non-rechargeable AED that generated significant buzz when it launched. It was promoted heavily on social media, endorsed by well-known medical professionals, and positioned as a game-changer for home and personal use.
So what went wrong?
The problem wasn’t the concept – it was the approach.
Novel medical technology requires clinical evidence, regulatory rigour, and time. Instead, the focus appeared to be on marketing spend and rapid market entry. When someone submitted an FOI request to the MHRA in late 2023 asking for clinical evidence – including evidence for claims that it was “equal or better than every other defibrillator on the market” – the regulator could only respond with “neither confirm nor deny.”
That should concern anyone responsible for AED procurement.
Why does this keep happening?
AEDs have increasingly been treated as commodities – just another item to tick off a compliance checklist. The attitude of “a defib’s a defib” has taken hold, even among medical professionals who should know better.
But these are life-saving medical devices. They sit unused for years, then need to work perfectly in the most stressful moments imaginable. The difference between a well-governed programme and a box-ticking exercise can be the difference between life and death.
What to look for
- Established manufacturers with proven track records and a UK presence
- Published clinical evidence and regulatory transparency
- A proper programme approach: training, maintenance, and consumable management
- Independent advice from someone who understands the technology, not just the price
If you’re affected
If you purchased a CellAED, the TGA notice is clear: do not use it, dispose of it safely, and note that no replacement stock will be available.
I am offering a trade-in for anyone looking to replace their CellAED with a properly supported solution.
After nearly 30 years in this industry, I’ve seen products come and go. The ones that endure are those built on evidence, not just enthusiasm.
Sources
- TGA Critical Recall notice:
https://www.tga.gov.au/safety/recalls-and-other-market-actions/market-actions/cellaed-non-rechargeable-public-automated-external-defibrillator - MHRA Field Safety Notice (November 2024):
https://www.gov.uk/drug-device-alerts/field-safety-notices-25-november-2024 - MHRA FOI response (FOI 24/011):
https://assets.publishing.service.gov.uk/media/668d23d8ab5fc5929851bc14/FOI_24-011_final_redaction.pdf
CellAED: Non-rechargeable public automated external defibrillator
The company which supplied the CellAED devices, RRR Manufacturing Pty Ltd, has gone into liquidation.
