FDA (Devices) recall action 64130
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table height measurements out of specification with the consequence of potential system mis-alignment.
Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates have been used
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 Healthcare Inc. is recalling 101 units of Diagnost Stationary Radiographic Systems because installation records show table height measurements out of specification.
Philips Healthcare is recalling 177 stationary radiographic systems because their Installation Acceptance Test Documents were non-compliant with regulations or could not be located.