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U.S. Department of Health and Human Services

Class 2 Device Recall Hill Rom

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  Class 2 Device Recall Hill Rom see related information
Date Initiated by Firm May 28, 2021
Create Date July 28, 2021
Recall Status1 Terminated 3 on June 06, 2024
Recall Number Z-2156-2021
Recall Event ID 88185
510(K)Number K915779  
Product Classification Table, obstetric (and accessories) - Product Code KNC
Product Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E
Code Information Serial Numbers: US Serial Numbers: P328AA3855 P314AA3735 P311AA3734 P311AA3733 P304AA3675 I067AA5445 O351AA1238 J130AA8820 K226AA1383 I135AA6134 O161AA3 P314AA3737 P343AA3930 P343AA3929 P343AA3920 P343AA3919 P343AA3918 P314AA3736 P323AA3813 P323AA3812 P322AA3811 P322AA3810 P322AA3809 P322AA3808 I004AA4998 I156AA6325 P295AA3605 I267AA7216 J155AA8988 J161AA9040 J168AA9110 J168AA9099 J162AA9047 J154AA8977 P346AA3966. OUS: Serial Numbers: I299AA7436 O004AA0116 M117AA5556 M115AA5531 M115AA5527 P286AA3531 N124AA8303 M055AA5218 M053AA5199 P106AA2178 M160AA5829 M166AA5877 M053AA5198 M172AA5924 M180AA5992 M180AA5990 P288AA3551 M054AA5210 M054AA5202 P274AA3445 N199AA8761 M054AA5205 N083AA7986 M166AA5872 N121AA8271 P275AA3452 P283AA3524 P274AA3441 N017AA7471 P288AA3552 N272AA9378 N017AA7473 M049AA5176 P281AA3497 P279AA3471 N018AA7480 P280AA3486 N089AA8038 M166AA5880 M075AA5294 N090AA8040 N083AA7988 O197AA0505 O196AA0502 O108AA0048 N074AA7913 N124AA8304 M053AA5193 M052AA5182 P280AA3490 P077AA1935 P276AA3466 P008AA1340 N121AA8268 M055AA5217 O102AA0004 M052AA5187 M052AA5179 O193AA0496 M167AA5881 M054AA5208 O270AA0973 P276AA3469 P276AA3468 N272AA9377 N269AA9354 O275AA1002 O270AA0976 O270AA0969 O269AA0965 O197AA0511 N090AA8043.2 N075AA7929 P276AA3465 M054AA5206 O102AA0003 O060AA0560.2 O060AA0557 N272AA9387 P083AA1984 P030AD1533 P030AA1533 P276AA3464 P274AA3443 P094AA2085 P094AA2083 P093AA2080 P094AA2089 P094AA2091 P078AA1947 O324AA1021 O016AA0202 N128AA8319 N024AA7514 N018AA7478 N017AA7476 M111AA5521 M105AA5471 M104AA5469 M104AA5467 M090AA5413 M090AA5412 M090AA5409 M090AA5407 M055AA5213 M054AA5209 M054AA5201 M052AA5188 M052AA5186 M052AA5184 M052AA5183 M049AA5175 M049AA5174 P190AA2741 P300AA3633 J011AA7835 J011AA7833 L160AA3472 L159AA3463 L175AA3633 L071AA2745 N129AA8337 K006AA0517 K293AA1756 O213AA06O2 O213AA0609 O213AA0607 O213AA0602 O212AA0600 N198AA8751 N122AA8281 N122AA8280 N122AA8279 N122AA8278 N209AA8850 N002AA7346 M325AA7097 M322AA7084 M285AA6767 L075AA2765 I325AA7566 I310AA7504 I310AA7503 I310AA7499 I310AA7498 P237AA3105 P091AA2052 P077AA1929 I046AA5284 L287AA4319 K197AA1215 K197AA1213 K197AA1212 K196AA1211 K196AA1210 K196AA1208 K196AA1207 N285AA9479 N285AA9478 I025AA5154 I024AA5150 I024AA5148 I018AA5106 P231AA3059 L342AA4680 I236AA6915 J302AA0301 I082AA5617 L050AA2500 L050AA2499 L050AA2498 L049AA2494 N039AA7647 N177AA8633 N174AA8630 J200AA9360 N010AA7413 N010AA7412 N010AA7411 O029AA0313 O029AA0311 O029AA0309 O029AA0308 N199AA8763 N191AA8688 N181AA8686 N181AA8682 K238AA1474 P288AA3556 P288AA3554 P288AA3553 P288AA3550 M223AA6272 I281AA7323 I281AA7321 P157AA2561 P157AA2560 P157AA2559 L051AA2511 P174AA2674 P174AA2614 L299AA4411 L299AA4409 L299AA4407 L299AA4405 L299AA4403 L286AA4318 L286AA4316 N347AA9987 N347AA9986 J234AA9790 J231AA9737 O023AA0264 O102AA0008 O095AA0786 O095AA0785 O095AA0784 O095AA0783 O095AA0782 O095AA0781 O095AA0780 P347AA3978 P347AA3976 P347AA3975 P344AA3936 P347AA3977 N195AA8731 P330AA3871 P330AA3869 P328AA3854 P328AA3853 P328AA3850 P328AA3848 P328AA3846 P328AA3845 P325AA3844 P325AA3843 P325AA3841 P325AA3840 P325AA3838 P325AA3837 P325AA3836 P325AA3835 P325AA3834 P302AA3657 P302AA3656 P325AA3839 P276AA3460 P276AA3459 K044AA0724 P029AA1521 P029AA1519 N202AA8795 N062AA2828 N061AA7801 N026AA7530 N024AA7523 L034AA2398 L034AA2397 K292AA1745 K254AA1596 K044AA0725 J157AA9006 I010AA5040 I010AA5039 I009AA5038 I009AA5037 I009AA5036 I009AA5035 P058AA1748 O212AA0593 K083AA0889 K082AA0882 J351AA0471 J350AA0470 J350AA0469 J197AA9320 J197AA9316 J189AA9237 J189AA9234 I200AA6600 I135AA6132 N216AA8908 P297AA3624 P241AA3160 P190AA2742 P190AA2738 P029AA1517 O201AA561 N317AA9701 N298AA9588 N219AA8910 N219AA8909 N208AA8840 N122AA8283 M311AA6994 M311AA6993 M311AA6992 M209AA6161 M129AA5632 M081AA5334 M046AA5138 L034AA2401 L027AA2342 K083AA0884 K082AA0881 K058AA0812 K055AA0798 I200AA6596 I158AA6348 P139AA2419 P030AA1529 P016AA1417 N216AA8907 P167AA2620 P153AA2520 N201AA8778 M279AA6719 M279AA6717 M272AA6670 M272AA6669 K217AA1313 K217AA1312 L203AA3742 I135AA6135 K226AA1382 K013AA0560 N005AA7380 I164AA6392 M202AA6103 L223AA3826 M178AA5984 P190AA2740 K202AA1233 I165AA6397 K324AA1983 L274AA4213 L208AA3781 I074AA5521 N219AA8911 K341AA2070 K341AA2068 K334AA2013 O206AA0556 M272AA6671 L313AA4520 I143AA6235 I284AA7358 L152AA3387 I299AA7436 J305AA0329 M011AA4880 L091AA2937 L252AA4058 L251AA4057 L091AA2938 L152AA3394 M125AA5617 I143AA6234 M322AA7088 P154AA2525 I164AA6391 I144AA6240 M279AA6720 L281AA4277 L281AA4276 M221AA6250 I144AA6243 I095AA5715 K364AA2155 K338AA2066 K338AA2064 I095AA5724 I095AA5717 I095AA5714 I081AA5608 L356AA4793 L350AA4747 L350AA4745 J283AA0161 J274AA0099 J289AA0205 J289AA0203 J009AA7818 I306AA7487 I306AA7486 L288AA4336 L288AA4335 K252AA1574 K252AA1572 L144AA3316 J235AA9828 M075AA5293 L123AA3127 L120AA3125 L120AA3124 L120AA3122 L120AA3121 N107AA8159 I267AA7219 I267AA7218 M279AA6718 J233AA9786 J233AA9783 K289AA1735 J235AA9826 J319AA0374 J297AA0264 K364AA2154 K364AA2147 K238AA1468 K127AA0972 K127AA0971 K176AA1183 K364AA2151 P030AA1523 I057AA5360 L152AA3386 L299AA4410 J010AA7821 J010AA7820 J010AA7819 L071AA2744 M222AA6257 I354AA7757 K070AA0830 K070AA0829 K070AA0826 I334AA7615 L015AA2243 I135AA6136 I124AA6027 L034AA2393 L194AA3665 L193AA3663 L193AA3661 M018AA4937 N114AA8210 L082AA2845 K229AA1385 I080AA5588 I032AA5204 I031AA5202 I031AA5201 I031AA5200 M049AA5173 L251AA4056 M279AA6721 N353AA0054 O037AA0372 I051AA5316 M312AA7000 M018AA4934 M017AA4926 M012AA4887 I129AA6068 J283AA0163 L075AA2767 L203AA3741 J189AA9238 K055AA0793 J319AA0373 K058AA0813 I095AA5711 I094AA5707 I094AA5706 I094AA5705 I094AA5711 H126AA5629 J199AA9345 J199AA9342 K071AA0831 O037AA0379 M017AA4931 M012AA4889 M011AA4883 M201AA6097 M178AA5964 N313AA9681 I299AA7434 P301AA3647 L123AA3128 J039AA8036 L351AA4760 K168AA1136 L312AA4510 M166AA6871 M165AA6869 M165AA5869 L152AA3392 L152AA3389 M313AA7016 M313AA7013 J053AA8141 N208AA8833 N207AA8831 N207AA8827 P087AA2034 P080AA1978 P065AA1817 P063AA1788 P058AA1745 P058AA1744 P058AA1741 P058AA1740 P020AA1440 O329AA1056 O284AA0704 O283AA0686 O219AA0643 O218AA0640 O218AA0637 O212AA0597 O212AA0596 O212AA0594 O207AA0561 O037AA0377 O036AA0366 O036AA0364 O036AA0363 O036AA0361 O036AA0359 O035AA0355 O035AA0353 O035AA0350 O016AA0204 N234AA9043 N234AA9042 N233AA9020 N233AA9019 N208AA8837 N208AA8835 N207AA8829 N207AA8824 N205AA8807 N202AA8794 N199AA8757 N199AA8755 N198AA8752 N195AA8732 N193AA8710 N193AA8709 N192AA8708 N181AA8680 N180AA8674 N177AA8632 N143AA8439 N136AA8381 N083AA7992 N062AA7828 N020AA7501 M286AA6787 M280AA6734 M213AA6179 M208AA6145 M166AA5871 M159AA5822 M126AA5629 M021AA4977 L356AA4792 L350AA4749 L250AA4039 L172AA3582 L160AA3469 L159AA3468 L144AA3305 L140AA3283 L123AA3130 L123AA3129 L074AA2762 L070AA2728 L051AA2519 L050AA2509 K293AA1751 K292AA1749 K292AA1748 K252AA1571 K239AA1476 K084AA0896 K077AA0858 K041AA0700 J263AA0021 J263AA0019 J224AA9634 J217AA9532 J199AA9346 J197AA9313 J197AA9312 J066AA8275 J066AA8272 J056AA8149 J018AA7880 J017AA7878 I068AA5468 I047AA5294 H338AA4821 I068AA5471 L153AA3409 P098AA2112 O206AA0550 O206AA0549 N066AA7848 N065AA7838 O284AA0706 P288AA3555 I257AA7131 M203AA6121 M271AA6657 M270AA6645 M203AA6119 L267AA4151 K364AA2148 I067AA5447 N213AA8875 O291AA0751 O290AA0741 O288AA0721 P218AA2955 P206AA2866 P203AA2829 J088AA8513 O011AA0167 P218AA2957 P212AA2909 P212AA2908 P212AA2906 P211AA2904 P204AA2850 P204AA2849 P202AA2817 P199AA2814 P197AA2792 O011AA0168 O010AA0166 O010AA0165 O010AA0161 O009AA0154 O009AA0153 O008AA0135 O003AA0110 O003AA0107 P241AA3162 P059AA1753 O053AA0505 O032AA0339 O031AA0333 P058AA1743 J198AA9333 O002AA0098 O002AA0096 O002AA0095 P058AA1742 P058AA1747 M136AA5692 O042AA0405 P241AA3158 P311AA3725 P297AA3627 P293AA3619 P241AA3157 P241AA3155 P241AA3153 M228AA6301 J178AA9212 P240AA3145 P087AA2032 P087AA2031 P245AA3164 L082AA2843 P241AA3156 L081AA2837 P240AA3143 P171AA2655 P240AA3151 P240AA3149 P240AA3147 J193AA9288 J193AA9286 J193AA9285 J193AA9283 O030AA0323 O030AA0320 O030AA0317 M321AA7076 P059AA1752 P045AA1642 O031AA0332 O031AA0331 O031AA0330 P058AA1746 O031AA0329 H348AA4902 L153AA3401 O045AA0440 O045AA0438 O045AA0436 O044AA0434 O044AA0429 O044AA0428 O044AA0427 O044AA0425 O043AA0423 O043AA0421 O043AA0419 O043AA0418 O043AA0414 O042AA0412 O042AA0410 O042AA0408 O042AA0407 O042AA0406 O043AA0416 P301AA3644 P301AA3643 P301AA3641 P301AA3640 P301AA3639 N109AA8175 O018AA0233 O023AA0267 O023AA0265 O023AA0263 O023AA0257 O023AA0253 O022AA0269 O022AA0255 O022AA0253 O021AA0239 O021AA0235 O018AA0231 O018AA0229 P300AA3632 P290AA3573 P297AA3622 P297AA3621 P297AA3620 P295AA3602 P294AA3599 O015AA0197 O015AA0195 O217AA0623 O214AA0620 O214AA0614 O214AA0611 P093AA2072 O023AA0262 L313AA4519 K231AA1416 M222AA6252 K231AA1411 K231AA1409 P301AA3642 P297AA3623 P290AA3571 O212AA0601 O212AA0599 O211AA0588 O211AA0587 O211AA0586 M048AA5160 M048AA5159 M048AA5158 M048AA5156 N326AA9792 P230AA3054 M223AA6271 N212AA8856 N209AA8846 P027AA1497 P093AA2074 O016AA0200 P063AA1791 P063AA1790 P010AA1370 P010AA1369 I324AA7550 K231AA1407 I166AA6412 I155AA6315 I033AA5214 K231AA1413 I032AA5212 P286AA3529 O106AA0023 P031AA1540 P031AA1536 P007AA1327 P007AA1325 P003AA1304 P003AA1303 P003AA1302 P002AA1294 O105AA0022 O105AA0021 O102AA0002 O021AA0240 O010AA0163 N335AA9867 N256AA9242 MO76AA5299 MO53AA5196 MO53AA5191 MO53AA5190 P283AA3521 P281AA3501 P281AA3499 P280AA3488 P280AA3484 P275AA3450 P275AA3448 P098AA1947 P077AA1934 P076AA1923 M076AA5299 M053AA5191 M053AA5190 M053AA5196 P059AA1751 P125AA2305 P125AA2303 P087AA2033 P017AA1426 O212AA0598 N356AA0081 N303AA9619 M340AA7203 M340AA7202 M081AA5332 M027AA5018 L035AA2403 K292AA1742 K292AA1739 K026AA0651 K023AA0650 K023AA0649 K023AA0648 K023AA0647 K023AA0646 K023AA0645 K023AA0644 K023AA0643 K023AA0642 K023AA0641 K022AA0640 K022AA0639 J095AA8565 J095AA8563 J095AA8561 J094AA8556 I089AA5674 I085AA5634 I024AA5152 H352AA4924 H346AA4882 L195AA3683 P092AA2069 P092AA2065 P092AA2063 P091AA2058 P091AA2056 P091AA2054 N268AA9333 N265AA9329 N265AA9327 N265AA9325 N265AA9323 N263AA9308 N263AA9306 N179AA8661 O039AA0396 O039AA0392 O305AA0878 O303AA0843 K007AA0524 O039AA0401 O218AA0641 O219AA0642 O206AA0555 P286AA3525 L335AA4617 P233AA3134 P233AA3132 N179AA8663 P210AA2890 P302AA3651 I288AA7378 I288AA7374 I290AA7390 I289AA7386 I288AA7377 I285AA7363 I285AA7359 I284AA7357 I282AA7338 I282AA7331 K006AA0507 J192AA9277 L071AA2740 P045AA1645 P045AA1644 P232AA3075 P224AA3000 O035AA0352 N019AA7492 P232AA3077 M056AA5226 M021AA4970 L335AA4625 L335AA4624 L335AA4622 L335AA4621 L334AA4610 L063AA2649 K245AA1528 K244AA1519 K015AA0587 K007AA0525 K007AA0522 K005AA0507 J351AA0478 J212AA9465 J211AA9456 I288AA7376 I282AA7332 I281AA7329 I257AA7133 I225AA6788 O302AA834 O042AA0403 O302AA832 O302AA0878 J178AA9213 J176AA9184 J176AA9182 N265AA9324 P027AA1495 P015AA1401 O283AA0688 P017AA1423 P016AA1421 P016AA1419 P016AA1416 P016AA1420 P030AA1525 P029AA1515 K083AA0887 O283AA0689 M284AA6765 M283AA6751 L166AA3539 K309AA1895 K308AA1869 P017AA1422 J004AA7783 K138AA1018 K135AA1016 K135AA1014 J287AA0190 K077AA0860 K069AA0823 J298AA0274 J193AA9279 J165AA9098 K071AA0832 M203AA6120 J102AA8614 J066AA8270 O052AA0491 L208AA3782 L140AA3284 K225AA1371 J353AA0500 I033AA5216 J025AA7938 I180AA6507 P308AA3693 P342AA3914 P342AA3913 P342AA3912 P287AA3544 P287AA3542 P216AA2935 P198AA2802 P190AA2746 P188AA2718 P188AA2716 O010AA0158 M300AA6917 P211AA2902 I037AA5242 O201AA0571 P024AA1478 N222AA8945 N004AA7368 N117AA8252 P217AA2946 P199AA2808 J263AA0022 N167AA8570 L211AA3819 L211AA3814 L210AA3808 N118AA8256 N118AA8255 N118AA8254 N118AA8251 N223AA8959 P219AA2962 P206AA2864 P205AA2852 P204AA2843 P204AA2841 P203AA2839 P203AA2836 N145AA8460 P216AA2933 P199AA2807 P199AA2806 P199AA2811 P198AA2803 P199AA2809 P198AA2804 I218AA6729 P177AA2704 P217AA2942 P191AA2749 P203AA2838 N299AA9569 I022AA5129 O290AA0745 P121AA2287 P121AA2286 P022AA1455 P017AA1431 N003AA7357 N223AA8958 N173AA8619 P213AA2916 P212AA2915 P206AA2867 P192AA2769 P212AA2913 P217AA2938 P217AA2948 P217AA2944 P212AA2912 I212AA2912 K057AA0808 K057AA0805 K043AA0715 K068AA0822 J043AA8056 P003AA1300 M005AA4836 H347AA4900 P199AA2810 O354AA1278 N223AA8955 N214AA8877 N111AA8201 N110AA8193
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information Contact Howard Karesh
312-237-6188
Manufacturer Reason
for Recall		 Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall.
FDA Determined
Cause 2		 Device Design
Action Hill Rom Issued Urgent Medical Device Correction Subject: Affinity Four Birthing BedLift-Off Foot Section REF: MOD1331 issued on 05/28/21 to Facility Risk Manager; Facility Administrator; Facility Engineer; Vigilance Manager; Biomedical Engineering; Medical Device Liaison Officer; Distributor, stating reason for recall, health risk and action to take: Verify that the Lift-Off foot section has already been updated with the new Latch Bracket and Foot Section receivers and has adequate engagement into the receivers as noted in the graphics below. Be aware that the foot section has the potential to fall if the latch brackets and foot section receivers have not been updated and are damaged. Refer to Figures 2 and 3 below and complete the following inspection process to determine if your Latch Bracket and Foot Section receiver have adequate engagement. Action to be taken by the distributor: Please share with your end users to instruct them on completing their inspection test outlined above. Complete the attached response form and return to hillrom1331@stericycle.com without delay. Contact hillrom1331@stericycle.com to receive an electronic copy of this notification and response form for onward distribution. Hillrom will mitigate this risk through an update to the Lift-Off foot section and will contact you to coordinate the update. Once the product has been updated, some customers who utilize the P278 Hillrom Instrument Tray, may encounter issues fitting the tray. These original version trays will be replaced, as needed, at the time of the update. If you have any questions regarding this safety notice, please contact Hillrom Technical Support at 800-445-3720 or us.service@hillrom.com.
Quantity in Commerce 1,096 Beds
Distribution Worldwide distribution - US Nationwide distribution in the states of AL, CA, IA, MS, NC, NY, OH, PA, TX, VA and the countries of Australia, Austria, Azerbaijan, Belgium, Chile, China, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNC and Original Applicant = HILL-ROM, INC.
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