In a statement to Telecare Aware, a spokesperson for Philips in the US denied rumours that the replacement of equipment to Health Watch customers earlier in the year was a recall related to the FDA’s warning letter in February about insufficiently robust quality processes in the Health Watch facility in Boca Raton, which it had acquired the year before.
Andre Manning of the Philips Healthcare communications team said: “In April of last year, we announced the acquisition of Health Watch. Over the next 18 months, Philips Lifeline worked with Health Watch’s existing customer base to update the Health Watch units in their homes with new equipment from Philips Lifeline. The change in the equipment was done at no cost to the customer nor did it interrupt the monitoring service. For optimal operational support and monitoring service, it was necessary to have all customers using the Lifeline units. There was no “recall” of units produced by Health Watch. It was a swap of equipment so that we could best service each of our customers. There is no connection whatsoever between the FDA audit in the Boca Raton facility and the swap out.”
Interestingly, the Health Watch website is still live. On the page that announced its partnership with Tunstall in pre-Philips sale days, it says
Health Watch has continually pioneered advanced technologies and innovative services in Personal Response Monitoring…Working with Tunstall Group, Health Watch has initiated the most dynamic research and development effort in the industry, giving Subscribers and Providers open access to the world’s newest Telecare solutions. Our next generation monitoring technologies help to assure independent living and personal security for more people than ever before.
Hmm… is this a case of “Beware, your hype will always find you out”?
Update: 5 December 15:30
Richard Farrell Smith, Product Communications Manager, Tunstall Group sent the following comment for clarification:
I read with interest your article on HealthWatch however I am concerned that it implies a connection between the FDA letter and products supplied by Tunstall. The FDA letter does in fact refer to alarm units (HW3000 and HW6000) that were manufactured by HealthWatch prior to its relationship with Tunstall. These units are easily confused with the units that Tunstall did supply to HealthWatch (HW3000T and HW 6000T). Although the FDA letter does cover more than just the manufacturing of the units, I would appreciate it if you could clarify that none of the issues relate to Tunstall and the manufacturing issues relate specifically to units manufactured by HealthWatch.
Richard – Thanks for the further clarification. There have been a number of rumours going round about this which I’m pleased to lay to rest. Steve