FDA (Devices) recall action 64128
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.
An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used
An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment
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 66 BuckyDiagnost Radiographic X-ray systems because installation acceptance test documentation was missing or inconsistent.
Philips Healthcare is recalling 116 BuckyDiagnost radiographic systems because table height measurements were found out of specification, potentially causing system mis-alignment.