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Welch Allyn, Inc.
WELCH ALLYN, INC. · Model 901138 · UDI-DI 00732094313857
10
510(k) clearances
33,126
Adverse events (1,928 deaths)
294
Recalls
118
Facilities
Description
Surveyor S12 GEN2 Patient Monitoring System - Surveyor Sp02, ECG, Dual Temp, NIBP, No IBP, resistive color touchscreen 11.6" display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; IEC 5 wire ECG patient cable with clip ends; No invasive blood pressure cable; No cardiac output cable; No printer; LAN; No mounting options
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-16 | Philips North America | Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity t |
| 2026-09-08 | Nihon Kohden America LLC | Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds |
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2026-07-31 | Philips North America | Due to software malfunction, patient information system may freeze and become unresponsive. |
| 2026-07-31 | Philips North America | Due to software malfunction, patient information system may freeze and become unresponsive. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.