FDA Device recall Z-0239-2019
Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 7…
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 7… by Philips Medical Systems Dmc, citing stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0239-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-19 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Dmc |
| Distribution | US |
Product
Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
Reason
Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline
Identifiers
| code_info | Software 4.1.x and 4.2.x Serial Numbers: 547772/SN14000040 549865/SN14000071 SN14000090 554080/SN15000110 SN15000…Software 4.1.x and 4.2.x Serial Numbers: 547772/SN14000040 549865/SN14000071 SN14000090 554080/SN15000110 SN15000165 SN15000174 SN15000173 SN15000180 SN15000189 SN15000190 SN15000192 SN15000196 SN15000225 SN15000264 SN15000281 SN15000283 SN15000282 SN15000288 SN15000291 SN15000298 SN15000304 SN15000303 SN15000327 SN15000153 SN15000152 SN15000350 563654/SN15000364 SN15000355 SN15000364 SN15000371 SN15000372 SN15000374 SN15000373 SN15000379 SN15000433 SN15000443 SN15000442 SN15000444 SN15000449 SN16000008 SN16000023 SN16000025 SN16000037 SN16000043 SN16000050 SN16000063 SN16000073 SN16000095 SN16000092 SN16000105 SN16000104 SN16000113 SN16000112 SN16000123 SN16000124 SN16000137 SN16000143 SN16000142 SN15000211 SN16000146 SN16000147 SN16000151 SN16000151 SN16000156 SN16000158 SN16000165 SN16000191 SN16000197 SN16000214 SN16000225 SN16000234 SN16000236 SN16000237 571802/SN16000253 SN16000253 SN16000263 SN16000264 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0239-2019%22
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