Hong Kong’s Department of Health issued a warning that Medela breast pumps with detachable power plugs have been associated with the risk of electrical shock.

The alert covers the UK (Type G) detachable power plugs of three models of Medela breast pumps.

The manufacturer is launching a voluntary replacement program for the detachable power plugs, which connect to a power supply base. Since June 2012, the manufacturer has marketed both breast pump systems and replacement power supplies (with enclosed plug adapters). The Medela breast pumps with affected detachable power plugs are Swing Maxi, Swing and Freestyle.

The voluntary replacement program only applies to detachable power plugs for UK sockets. Other products or power supply adapters for other sockets are not affected.

If users apply a certain level of force while removing affected detachable power plugs from UK sockets, the detachable power plugs might break apart potentially exposing live parts.

Compliance with IEC 62304 is required for all electromedical devices where basic safety or essential performance depends on software or firmware. However, many devicemakers — especially small to mid-size companies — are unaware that their devices must meet this standard. The confusion seems to stem from the fact that the guidance is called both “voluntary” and "mandatory." Clear up the confusion by purchasing a copy of FDAnews exclusive Device Software Safety Risks: Standards Lead to Closer FDA Scrutiny.