FDA Device recall Z-2758-2020
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualiz…
- FDA Device
- Class II
- terminated
- Published 2020-08-12
On 2020-08-12 the FDA classified a Class II recall of SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualiz… by Siemens Medical Solutions Usa, citing two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2758-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-08 |
| Published | 2020-08-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Reason
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis
Identifiers
| code_info | Serial Numbers: 24576 24077 25409 24100 24213 24051 24531 24542 24038 24116 25699 25698 25089 25076 2529…Serial Numbers: 24576 24077 25409 24100 24213 24051 24531 24542 24038 24116 25699 25698 25089 25076 25297 25477 25056 24644 24221 25717 25647 25716 24256 24572 25366 25425 25020 24616 24275 25444 24433 24536 24340 24437 24033 25392 25006 25554 25506 25644 25666 25164 25619 25156 25677 25038 25151 25152 24401 25125 25093 24291 25369 24622 24624 24629 24630 24635 24636 24637 24640 25375 24613 24244 24615 25672 24155 24159 24237 24066 24106 24343 25458 24381 24394 24402 25217 25192 25260 25669 24495 24502 24666 24430 24432 25629 25196 24052 25547 24128 24420 25600 24611 24450 24154 24156 25427 25154 25678 24059 24467 24612 24614 24505 25542 25098 25205 24299 25058 25246 24599 24600 25607 25371 25374 25380 25391 25397 25398 25404 24048 24099 25292 25250 24263 25569 25097 25105 24660 24662 25403 25416 25459 25497 24436 25414 25047 24113 25204 25109 243 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2758-2020%22
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