Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GetingeLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Getinge US Sales with 12 device recalls. The most recent is a device recall dated Nov 13, 2019: Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 13, 2019 | Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000Class II · Sterile barrier system may be compromised | Device recalls |
| Aug 22, 2019 | The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine Class II · Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted | Device recalls |
| Jul 22, 2019 | Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.Class II · Reversed expiration and manufacturing date on the label | Device recalls |
| Jun 5, 2019 | PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in paClass II · The monitor displays an error message . The error message states "internal error restart or service". | Device recalls |
| Mar 20, 2019 | Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter Class III · Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes | Device recalls |
| Jan 8, 2019 | Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to supporClass II · The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is | Device recalls |
| Jan 8, 2019 | Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A Product Usage: This product is desigClass II · The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is | Device recalls |
| Jan 8, 2019 | Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product is Class II · The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
