Agency classClass IIOur severity:High FDA (Devices)·Z-0231-2023·Announced 2022-11-23

Progressa hospital bed compression links may bend during head raising

Baxter Healthcare is recalling 248 Progressa bed systems. Compression links may bend when raising the head section, even with patients under 500 pounds.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a structural defect in a bed mechanism. Although no injuries have been reported, the compression links' potential to bend during normal operation poses a risk to patient safety, particularly given the malfunction can occur below the device's stated weight rating.

Plain-English summary

Baxter Healthcare Corporation is recalling 248 Hill-Rom Progressa bed systems identified by specific serial numbers. These beds are used in healthcare settings and are designed to support patients weighing up to 500 pounds.

The compression links on the affected beds may bend when the head section is raised. Although the bed's labeling specifies a maximum weight capacity of 500 pounds, the bending can occur in patients weighing less than this limit, depending on patient position on the bed. This malfunction could affect the proper operation of the bed mechanism.

The recalled beds were distributed throughout the United States (in Arizona, California, Colorado, Florida, Hawaii, Indiana, Louisiana, Massachusetts, Missouri, North Carolina, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, and Wisconsin) as well as internationally to Canada, Qatar, Singapore, United Arab Emirates, and Saudi Arabia.

Healthcare facilities and patients who own affected beds should stop using the bed if their serial number matches the recall list and contact Baxter Healthcare Corporation immediately for repair or replacement instructions. Refer to the FDA recall notice for the complete list of affected serial numbers.

The recalled product

Product: Hill-Rom Progressa Bed System
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Hospital Beds
Hazard: structural-defect
bed-mechanism-failure
Affected units: 248

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI/DI 00887761000100
Serial Numbers: X157AW7312
X206AW8017
X154AW7292
X166AW7416
X207AW8041
X158AW7351
X157AW7326
X157AW7313
X206AW8018
X154AW7293
X166AW7418
X167AW7449
X158AW7352
X157AW7328
X174AW7575
X206AW8019
X154AW7296
X167AW7428
X167AW7450

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Same manufacturer · Baxter Healthcare Corporation

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