Baxter Healthcare Corporation: Hill-Rom Progressa Bed System

Recall number

Z-0231-2023

Recalling firm

Baxter Healthcare Corporation

Product

Hill-Rom Progressa Bed System

Status

Open, Classified

Initiated

2022-10-18

Posted

2022-11-14

Terminated

not on file

Reason

The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur with a patient weight of less than 500 lbs. depending on the patient 's position on the bed.

Root cause

Under Investigation by firm

Action

Baxter/Hill-Rom disseminated an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 10/18/2022 by UPS Ground Service. The notice explained the issue and potential risk and requested the following: "Actions to be taken by Customer: " Please identify if you have the impacted beds per Appendix A in your facility and remove from service immediately. Serial number can be found on the patient right side of the bed under the head rail. Return the enclosed response form within two weeks, confirming serial numbers of impacted beds in your facility. Action to be taken by the Distributor: " Please share this Medical Device Correction Notice with your end users. " Complete response form and return to hillrom2022-045@Sedgwick.com within two weeks, identifying serial numbers of beds to be reworked. Hillrom will arrange shipment of replacement kit and associated instructions." "If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support at 800-445-3720 or technical.support@hillrom.com" Update: On 11/22/2022 (and some on 12/12/2022), the firm issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to additional consignees via UPS Ground Service which provided the same instructions as the initial notification but added 59 additional serial numbers in the Appendix of the notification.

Quantity

248 beds (Updated)

Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, IN, LA, MA, MO, NC, NM, NV, NY, OK, OR, PA, SC. TN, TX, WA, and WI. (UPDATED: States of PA and SC and there was government distribution.) There was no military distribution. Foreign distribution was made to Canada, Qatar, Singapore, and UAE. UPDATE: Saudi Arabia now included.

Lot, serial or model codes

UDI/DI 00887761000100, Serial Numbers: X157AW7312, X206AW8017, X154AW7292, X166AW7416, X207AW8041, X158AW7351, X157AW7326, X157AW7313, X206AW8018, X154AW7293, X166AW7418, X167AW7449, X158AW7352, X157AW7328, X174AW7575, X206AW8019, X154AW7296, X167AW7428, X167AW7450, X158AW7353, X157AW7329, X174AW7579, X206AW8021, X154AW7297, X167AW7429, X167AW7451, X158AW7354, X157AW7330, X181AW7722, X206AW8022, X154AW7298, X157AW7308, X166AW7419, X158AW7355, X157AW7332, X181AW7728, X206AW8023, X154AW7300, X157AW7309, X167AW7425, X206AW8010, X158AW7340, X182AW7736, X206AW8024, X168AW7456, X178AW7622, X167AW7427, X206AW8011, X158AW7341, X182AW7737, X206AW8025, X168AW7478, X178AW7623, X159AW7375, X206AW8012, X158AW7342, X207AW8060, X158AW7344, X171AW7495, X178AW7625, X159AW7378, X206AW8020, X158AW7343, X208AW8079, X206AW8026, X171AW7496, X178AW7626, X159AW7380, X158AW7333, X158AW7349, X208AW8082, X206AW8027, X171AW7497, X178AW7627, X216AW8193, X158AW7334, X158AW7359, X208AW8084, X206AW8028, X171AW7498, X178AW7628, X216AW8194, X158AW7336, X159AW7360, X157AW7305, X206AW8029, X172AW7521, X178AW7629, X168AW7468, X158AW7337, X159AW7361, X158AW7348, X206AW8030, X172AW7522, X154AW7288, X168AW7474, X158AW7338, X159AW7364, X164AW7390, X207AW8038, X172AW7531, X154AW7295, X171AW7481, X158AW7356, X159AW7367, X166AW7403, X207AW8039, X172AW7533, X159AW7370, X206AW8032, X158AW7358, X159AW7374, X167AW7433, X207AW8040, X172AW7534, X159AW7371, X207AW8036, X159AW7363, X159AW7383, X167AW7434, X180AW7693, X173AW7536, X174AW7565, X167AW7447, X154AW7302, X159AW7384, X167AW7435, X181AW7714, X173AW7537, X174AW7567, X172AW7528, X157AW7304, X159AW7385, X201AW7935, X181AW7720, X159AW7382, X199AW7872, X172AW7529, X157AW7316, X159AW7386, X201AW7940, X154AW7289, X166AW7405, X158AW7345, X173AW7539, X157AW7317, X159AW7387, X203AW8005, X154AW7294, X166AW7406, X158AW7346, X173AW7540, X157AW7318, X164AW7395, X203AW8006, X164AW7391, X166AW7407, X158AW7347, X173AW7542, X157AW7320, X166AW7396, X207AW8042, X164AW7392, X166AW7411, X154AW7301, X173AW7543, X157AW7321, X166AW7398, X207AW8043, X164AW7388, X166AW7412, X157AW7311, X173AW7545, X157AW7322, X166AW7399, X207AW8044, X164AW7393, X166AW7414, X159AW7365, X173AW7546, X157AW7324, X166AW7410, X207AW8045, X154AW7291, X166AW7415, X159AW7366, X158AW7350, X157AW7325, X154AW7290 ADDITIONAL SERIAL NUMBERS UPDATED 2/14/2023: X140AW7268, X140AW7269, X140AW7270, X140AW7271, X140AW7272, X140AW7253, X140AW7254, X140AW7255, X140AW7256, X140AW7257, X140AW7258, X140AW7259, X140AW7260, X140AW7262, X140AW7263, X139AW7226, X139AW7227, X139AW7228, X139AW7229, X139AW7230, X103AW6603, X103AW6604, X103AW6605, X103AW6606, X103AW6607, X103AW6608, X103AW6609, X103AW6610, X103AW6611, X103AW6612, X103AW6613, X139AW7232, X139AW7234, X139AW7236, X139AW7237, X139AW7238, X139AW7239, X139AW7240, X139AW7241, X139AW7242, X139AW7243, X140AW7245, X140AW7246, X140AW7249, X140AW7250, X140AW7251, X140AW7252, X140AW7273, X140AW7274, X140AW7275, X154AW7280, X139AW7231, X139AW7235, X139AW7244, X140AW7261, X140AW7264, X140AW7265, X140AW7266, X140AW7267

510(k) numbers

not on file

PMA numbers

not on file

Product code

FNL

Firm FEI

1417572

Firm city

Deerfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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