The Recall Desk

Manufacturer

Vital Signs Devices, a GE Healthcare Company

3 recalls in our database name Vital Signs Devices, a GE Healthcare Company as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2013-08-21

Of the 3 recalls from Vital Signs Devices, a GE Healthcare Company we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-1959-2013·2013-08-21

    GE Healthcare Recalls Disposable Temperature Probes Due to Safety Concerns

    GE Healthcare is recalling disposable temperature probes due to a potential safety issue with esophageal placement.

    Product
    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0330-2013·2012-11-28

    GE Healthcare Recalls Fetal Scalp Electrodes Due to Packaging Seal Issues

    Vital Signs Devices is recalling 126 cases of Corometrics Qwik Connect Plus Spiral Electrodes because 30 units had incomplete package seals and missing lot numbers.

    Product
    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2012·2012-07-18

    GE Healthcare Recalls enFlow IV Fluid Warmer Straps for Biocompatibility Issues

    Vital Signs Devices is recalling enFlow Warmer Straps because they do not meet biocompatibility standards for skin contact.

    Product
    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to adminis
    Category
    Medical Device
    Distribution
    Distributed nationwide