PlainRecalls

GE Healthcare, LLC

324 recalls on record · Latest: Aug 31, 2022

GE Healthcare, LLC Recall Insight

GE Healthcare, LLC appears on 324 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.386% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Aug 31, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 24 entries, severity tagging shows 3 critical, 21 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 24 of 24 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (24). The date window on this page runs from Jun 27, 2012 to Feb 20, 2013.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Critical Feb 20, 2013

Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Ma…

FDA Devices Moderate Feb 20, 2013

GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intr…

FDA Devices Moderate Feb 20, 2013

GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The syste…

FDA Devices Moderate Feb 20, 2013

GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.

FDA Devices Critical Jan 2, 2013

GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Pi…

FDA Devices Moderate Dec 26, 2012

GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patien…

FDA Devices Moderate Dec 26, 2012

Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more …

FDA Devices Moderate Dec 5, 2012

GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22O…

FDA Devices Moderate Dec 5, 2012

GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oam…

FDA Devices Moderate Dec 5, 2012

GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22O…

FDA Devices Moderate Nov 28, 2012

GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.

FDA Devices Moderate Nov 28, 2012

GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.

FDA Devices Moderate Nov 28, 2012

GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.

FDA Devices Moderate Oct 31, 2012

GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for …

FDA Devices Moderate Oct 31, 2012

GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection,…

FDA Devices Moderate Oct 31, 2012

GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for…

FDA Devices Moderate Oct 31, 2012

GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to …

FDA Devices Moderate Oct 31, 2012

GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for v…

FDA Devices Moderate Sep 19, 2012

Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.

FDA Devices Moderate Sep 19, 2012

GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane…

FDA Devices Moderate Sep 19, 2012

Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.

FDA Devices Moderate Jul 25, 2012

GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.

FDA Devices Moderate Jul 18, 2012

GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The …

FDA Devices Critical Jun 27, 2012

GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds