FDAClass IIAugust 29, 2018

DigitalDiagnost 4.1 High Performance recall

DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

Why was DigitalDiagnost 4.1 High Performance recalled?

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: SN15000291 SN16000158 SN15000374 SN15000298 SN16000191 SN15000327 SN17000317 SN16000321 SN16000063 SN15000364 SN15000444 SN16000143 SN15000443 SN16000037 SN15000371 SN15000303 SN16000137 SN16000329 SN16000095 SN16000308 SN16000328 SN16000043 SN16000151 SN15000442 SN16000147 SN16000146 SN16000050 SN16000271 SN16000253 SN16000073 SN16000296 SN16000297 SN16000311 SN16000263 SN16000371 SN16000214 SN16000142 SN16000025 SN16000165 SN16000105 SN15000264 SN16000264 SN16000302 SN16000113 SN16000112 SN16000123 SN15000373 SN15000165 SN16000347 SN16000375 SN15000355 SN16000225

Product
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
Recalling firm
Philips Medical Systems Gmbh, DMC
Distribution
US Nationwide; International to 66 countries
Recall date
August 29, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls