FDAClass IIMarch 25, 2020

OmniDiagnost Eleva System codes 708028 708027 recall

OmniDiagnost Eleva System codes 708028 708027

Why was OmniDiagnost Eleva System codes 708028 708027 recalled?

A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

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 codes 152 49 514 179 611 C@23273 46 560 555 464 14 90 198 15 326 143*003 451 267 FR90-111 417 59 390 164 135 23 143 80 219 24 78 73 15 79 109 624 71 44 576 70 460 62 98 63 620 147 100 68 122 422 12 54 490 97 138 20 130 67 ON100031011SN273 241 435 125 89 47 17 33 134 574

Product
OmniDiagnost Eleva System codes 708028 708027
Recalling firm
Philips North America, LLC
Quantity
69
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
Recall date
March 25, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls