OmniDiagnost Eleva System codes 708028 708027
FDA Recall #Z-1490-2020 — Class II — December 30, 2019
Product Description
OmniDiagnost Eleva System codes 708028 708027
Reason for Recall
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.
Recalling Firm
Philips North America, LLC — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
69
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated