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Hill-Rom Progressa Bed System recallZ-0231-2023 · Baxter Healthcare Corporation · initiated Oct 18, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected] 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 [email protected]" 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.

Recall details

Recall number
Z-0231-2023
Status
Open, Classified
Initiated by the company
Oct 18, 2022
Posted by the FDA
Nov 14, 2022
Recalling firm
Baxter Healthcare Corporation
Quantity
248 beds (Updated)
Product code
FNL
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.

Product description

Hill-Rom Progressa Bed System

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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