FDA (Devices) recall action 82978
The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head fork coating may crack, posing a risk of particles falling into the surgical field and causing patient infection.
Maquet is recalling 9 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
Maquet is recalling five VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
Maquet is recalling 12 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.
Maquet is recalling 7 units of VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field.
Maquet is recalling 65 VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field and causing patient infection.
Maquet is recalling 11 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
Maquet is recalling six VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field.
Maquet is recalling 46 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, risking particle contamination in the surgical field.
Maquet is recalling 10 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, potentially dropping particles into the surgical field.
Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.
Maquet is recalling 11 VOLISTA StandOP Surgical Lights because coating on the light head forks may crack, posing a risk of particles falling into the surgical field.