FDA Device Intelligence
HomeORTOTECSA SL › MOBILE WHIRLPOOL 398L (105 GAL) - 120V

MOBILE WHIRLPOOL 398L (105 GAL) - 120V

ORTOTECSA SL · Model G.18951/400 (120V) · UDI-DI 08436602170247

ILJ
10
510(k) clearances
1,022
Adverse events (43 deaths)
10
Recalls
8
Facilities

Recalls

DateFirmReason
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.