Recall Z-1964-2013— Philips Healthcare Inc.

Name: FDA recall Z-1964-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-11

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2013-06-11, terminated 2017-01-12. It names one FDA 510(k) clearance: K111725. Product: Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.. Reason: The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3)..

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-11
Terminated: 2017-01-12
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K111725 — MOBILEDIAGNOST WDRSedecal., Sa.·cleared 2011-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.

Reason for recall

The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).

Data sourced from openFDA. This site is unofficial and independent of the FDA.