Recall Z-2246-2020
Hill-Rom, Inc. · initiated April 30, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Centrella Smart+ Bed, Catalog Number P7900
Codes / lots: Serial codes anufactured between U290PF8145 through V015PF2473 plus the following serial codes outside this range that were updated during servicing: S237PF0789 T222PF6473 U067PF5719 U079PF6209 S248PF1062 T223PF6496 U067PF5722 U079PF6210 S249PF1117 T223PF6497 U067PF5725 U079PF6211 S254PF1218 T227PF6698 U071PF5783 U079PF6212 S255PF1262 T236PF7213 U071PF5788 U079PF6213 S256PF1300 T241PF7583 U071PF5789 U079PF6214 S257PF1353 T249PF8023 U071PF5790 U079PF6215 S300PF2244 T250PF8146 U072PF5798 U079PF6216 S303PF2287 T268PF9463 U078PF6163 U079PF6217 S303PF2306 T268PF9468 U078PF6166 U079PF6247 S305PF2366 T277PF9896 U078PF6169 U079PF6248 S331PF2510 T277PF9926 U078PF6171 U079PF6249 S332PF2554 T281PF0056 U078PF6173 U079PF6250 S333PF2570 T282PF0110 U078PF6174 U079PF6251 S339PF2673 T282PF0113 U078PF6175 U079PF6252 S340PF2717 T285PF0294 U078PF6176 U079PF6253 S346PF2865 T288PF0375 U078PF6177 U079PF6254 S347PF2912 T295PF0413 U078PF6178 U079PF6255 S347PF2919 T297PF0600 U078PF6179 U079PF6256 S354PF3029 T303PF0798 U078PF6180 U079PF6257 T002PF3078 T324PF1681 U078PF6181 U079PF6258 T003PF3090 T333PF2061 U078PF6182 U079PF6259 T003PF3099 T340PF2401 U078PF6183 U079PF6260 T003PF3101 T347PF2679 U078PF6184…
Reason for recall
The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit.
FDA-determined cause: Software design
Action taken
On April 30, 2020, the firm distributed Urgent Medial Device Correction letters to affected customers. Customers were informed that though the bed exit system will alert at the bed, it may fail to send a remote alert through the nurse call system. The firm's letter states that the risk can be immediately mitigated by changing the nurse call setting from "SideCom" to "With A.C." For detailed instructions, please see "Instructions: Changing the Nurse Call Setting" section of the letter. Customers should also complete the response form and return it to the firm. The latest software (version 1.28.000 or greater) resolves the communication issue and mitigates the potential patient risk. A software update to the latest software is required for affected devices. Once Hill-Rom receives your response form and has confirmed that your device is affected, the firm will contact you to schedule your software update. If you have any questions or would like to proactively schedule your software update, please contact Hill-Rom Technical Support at 1-800-445-3720 (select option 2 and then select option 1) Monday through Friday, 8:00AM 5:00 PM EST.
Details
- Recall number
- Z-2246-2020
- Initiated
- April 30, 2020
- Terminated
- January 23, 2024
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Quantity
- 4381 beds
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada and Australia.
- Recalling firm
- Hill-Rom, Inc., Batesville, IN