CLASS II Device recall · Reported 25 Mar 2020 · FDA Enforcement Report

Allura CV20, system recalled by Philips North America

Philips North America is recalling Allura CV20, system, distributed nationwide in the US. The recall was initiated on 30 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNot distributed in US. Serial numbers 155 42 150 160 87 154 29 73 88 48 109 78 53 63 41 97 138 86 39 36 152 135 40 49 80 153 91 23 35 64 71 55 33 32 30 75 76 70 133 124 182 173 101 128 21 115 81 82 19 84 92 166 72 69 22 26 61 130 52 98 116 117 110 113 112 111 89 90 177 164 165 161 162 163 28 100 174 56 167 119 168 185 50 120 151 125 131 159 126 79 66 137 65 123 169 122 121 148 147 146 149 140 38 129 184 127 181 178 62 170 132 157 158 134 46 136 96 180 45 47 99 54 31 175 83 77 94 85

Quantity recalled128

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1493-2020
FDA event ID: 84756
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 30 Dec 2019
FDA classified: 13 Mar 2020
Reported: 25 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Dec 2019	Recall initiated by company
13 Mar 2020	Classified by FDA	+74 days
25 Mar 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Allura CV20, system code 722031

Where it was distributed

Nationwide domestic distribution. Foreign distribution worldwide.

Nationwide

Questions about this recall

Why was it 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.

Which lots are affected?

Not distributed in US. Serial numbers 155 42 150 160 87 154 29 73 88 48 109 78 53 63 41 97 138 86 39 36 152 135 40 49 80 153 91 23 35 64 71 55 33 32 30 75 76 70 133 124 182 173 101 128 21 115 81 82 19 84 92 166 72 69 22 26 61 130 52 98 116 117 110 113 112 111 89 90 177 164 165 161 162 163 28 100 174 56 167 119 168 185 50 120 151 125 131 159 126 79 66 137 65 123 169 122 121 148 147 146 149 140 38 129 184 127 181 178 62 170 132 157 158 134 46 136 96 180 45 47 99 54 31 175 83 77 94 85

Where was it sold?

Nationwide domestic distribution. Foreign distribution worldwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 84756

This product is part of a recall event; the main page for the event is Integris Allura 9, system codes recalled by Philips North America.

Reported	Class	Recall	Company	Reason	Where
25 Mar 2020	CLASS II	Integris Allura 9, system codes recalled by Philips North America	Philips North America	Other	Nationwide
25 Mar 2020	CLASS II	Cardio Vascular-Allura Centron, system recalled by Philips North America	Philips North America	Other	Nationwide
25 Mar 2020	CLASS II	UroDiagnost Eleva, system recalled by Philips North America	Philips North America	Other	Nationwide
25 Mar 2020	CLASS II	OmniDiagnost Eleva System codes recalled by Philips North America	Philips North America	Other	Nationwide
25 Mar 2020	CLASS II	Integris Allura 15 & 12, monoplane (system recalled	Philips North America	Other	Nationwide
25 Mar 2020	CLASS II	MultiDiagnost Eleva, System codes recalled by Philips North America	Philips North America	Other	Nationwide
25 Mar 2020	CLASS II	Poly G Integris H5000, System recalled by Philips North America	Philips North America	Other	Nationwide
25 Mar 2020	CLASS II	Allura Exper FD Series recalled by Philips North America	Philips North America	Other	Nationwide

More recalls from Philips North America

All 531

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9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel recalled	Philips North America	Device Malfunction	MA
26 Aug 2026Device	CLASS II	Cardiac Workstation recalled by Philips North America	Philips North America	Labeling Errors	Nationwide

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