Business area Extended Care’s production facility for patient handling equipment in Gloucester, UK, has had a temporary ban imposed on it by the FDA for deliveries to the US.

The source of the ban was an inspection carried out at the Gloucester facility by the FDA in August 2004, after which the FDA commented about the quality assurance system. According to the FDA their comments have not been taken into consideration sufficiently, nor have proper measures been taken within a reasonable period following the inspection. The current situation is that Extended Care has carried out all the imposed measures and strengthened the management functions of the quality assurance system at the Gloucester facility. The business area has also consulted external experts to ensure that the quality assurance system complies with the FDA’s requirements. Deliveries to the US market can be resumed as soon as a new FDA inspection, without any adverse comments, has been carried out at Gloucester. Extended Care has no information yet of a date for the new inspection. The FDA ban only affects the Gloucester facility. Deliveries from Extended Care’s patient handling facilities in Belgium and Canada are not affected, which means that there will still be deliveries of both active and passive patient lifters from these facilities to clients in the US. Getinge estimates that the loss of revenue as a consequence of the ban will mean a negative impact on profits of about SEK 15 million. Getinge, 21 February 2005 Johan Malmquist, president and CEO