The Recall Desk

Manufacturer

Shape Medical Systems, Inc

2 recalls in our database name Shape Medical Systems, Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2015-02-11

Of the 2 recalls from Shape Medical Systems, Inc 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.

1–2 of 2

  • HighFDA (Devices)·Z-1060-2015·2015-02-11

    Shape Medical Systems Recalls Cardiopulmonary Testing System Patient Interfaces

    Shape Medical Systems is recalling 564 disposable patient interfaces for the Shape-HF Cardiopulmonary Testing System because they may produce erroneous results, potentially leading to incorrect diagnosis and treatment.

    Product
    Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2051-2014·2014-07-23

    Shape HF Cardiopulmonary System Recalled for Software Upgrade Requirement

    Shape Medical Systems is recalling 800 Shape HF Cardiopulmonary Systems because a mandatory software upgrade is required before using specific Disposable Patient Interface lots to prevent erroneous testing results.

    Product
    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variable
    Category
    Medical Device
    Distribution
    Distributed nationwide