FDAClass IINovember 23, 2022

Hill-Rom Progressa Bed System recall: Labeling Error

Hill-Rom Progressa Bed System

Why was Hill-Rom Progressa Bed System 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Hill-Rom Progressa Bed System
Recalling firm
Baxter Healthcare Corporation
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.
Recall date
November 23, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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