510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-2170-2010

Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for low to moderate acuity...

Hill-Rom Inc. / initiated 2009-09-16 / Terminated / root cause: design
FDA source (opens on fda.gov)

Hill-Rom, Inc. began a recall of Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the... on . The reason FDA records is "The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the pivot pin E-ring, which could cause the E-ring to come off". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2170-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.
Product code
FNJ Bed, Manual
Reason for recall
The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the pivot pin E-ring, which could cause the E-ring to come off.
Root cause tag
design
FDA root cause
Device Design
Action
The firm sent an Urgent Field Safety Notice to its customers dated 9/16/2009. The letter identified the affected product, explained the reason for the recall, actions to be taken, and a contact reference. Customers are to locate the affected product, examine the pivot points and ensure the E-ring is present. If the E-ring is missing, then the affected bed is to be taken out of service. Customers' distributors or agents will contact them with a permanent fix. Questions should be directed towards Hill-Rom Technical Support.
Quantity in commerce
962 beds
Distribution
Worldwide Distribution -- Argentina, Bahrain, Bhutan, Brazil, Bulgaria, Chili, China, Columbia, Costa Rica, Ecuador, Egypt, Eritrea, France, Hong Kong, India, Indonesia, Iran, Iraq, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mexico, Morocco, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Syria, Taiwan, Thailand, Trinidad & Tobago, Turkey, United Arab Emirates, United States, Uruguay, Venezuela, and Vietnam.
Product codes and lots
J343BE4440, J343BE4441, J343BE4442, J343BE4443, J343BE4444, J343BE4445, J343BE4446, J343BE4447, J343BE4448, J343BE4449, J343BE4450, J343BE4451, J343BE4452, J343BE4453, J343BE4454, J343BE4455, J343BE4456, J343BE4457, K092BM1266, K092BM1267, K092BM1268, K092BM1269, K092BM1270, K092BM1271, K092BM1272, K092BM1273, K092BM1299, K092BM1300, K092BM1301, K092BM1302, K092BM1303, K092BM1304, K092BM1305, K092BM1306, K092BM1307, K093BM1308, K093BM1309, K093BM1310, K093BM1311, K093BM1312, K093BM1313, K093BM1314, K093BM1315, K093BM1316, K093BM1317, K093BM1318, K093BM1319, K093BM1320, K093BM1321, J233BM2121, J233BM2122, J233BM2123, J233BM2124, J233BM2125, J233BM2126, J233BM2127, J233BM2128, J233BM2129, J233BM2130, J233BM2131, J233BM2132, J233BM2133, J233BM2134, J233BM2135, J233BM2136, J233BM2137, J233BM2138, J233BM2139, J233BM2140, J233BM2141, J233BM2142, J233BM2143, J233BM2144, J233BM2145, J233BM2146, J233BM2147, J233BM2148, J233BM2149, J233BM2150, J233BM2151, J233BM2152, J233BM2153, J233BM2154, 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