FDA (Devices) recall action 68588
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
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.
Philips is recalling 18 Ingenia 3.0T MRI systems because incorrect M10 nuts were used instead of stainless steel nuts.
Philips Medical Systems is recalling 33 Ingenia 1.5T MRI systems because incorrect M10 nuts were installed on the rear cover set.
Philips is recalling 24 Ingenia 1.5T MRI systems because some units shipped between December 2013 and March 2014 were supplied with incorrect M10 nuts instead of A4 stainless steel nuts.
Philips is recalling 21 Ingenia 3.0T MRI systems because some were shipped with incorrect M10 nuts instead of A4 stainless steel nuts.