510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1818-2015Class II

Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift

Hill-Rom Inc. / initiated 2015-03-20 / Terminated / root cause: labeling and UDI

Hill-Rom, Inc. began a recall of Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift on . FDA classified it as Class II and gives the reason as "Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. If the lift arm assembly is manually lifted, the actuator can become damaged and get stuck in the highest position. If a...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1818-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. If the lift arm assembly is manually lifted, the actuator can become damaged and get stuck in the highest position. If a patient is lifted into the sling while the actuator is stuck, there is a potential risk of a free fall of the patient, resulting in minor or potentially catastrophic injuries.
Root cause tag
labeling and UDI
FDA root cause
Labeling design
Action
On 3/20/2015, URGENT Field Safety Notice notifications, dated 3/19/2015 were sent to US customers by e-mail and or courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are forward a copy of the letter to any other appropriate facility personnel. Additionally, the attached form should be completed and returned to Hill-Rom. Upon receipt, the firm will contact customers to schedule an inspection of the potentially affected devices. For questions, call 800-445-3720 (Mon - Thurs, 8 am - 6:30 pm; Friday, 8 am - 6 pm).
Quantity in commerce
24, 798
Distribution
Worldwide Distribution -- AE, AO, AR, AT, AU, AZ, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CS, CZ, DE, DK, EG, ES, FI, FR, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, LB, LI, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PH, PL, PT, QA, RO, SA, SE, SG, SI, SK, SY, TH, TN, TR, TW, UK, US, VE, and ZA.
Product codes and lots
Viking¿ M Lift  Model 2040035 (S/N 9 200 000 - 9 201 689)  Model 2040015 (S/N 7 500 401 - 7 568 899)  Model 2040005 (S/N 7 100 101 - 7 200 200) Viking¿ L Lift  Model 2040004 (S/N 7 200 201 - 7 300 300) Viking¿ XL/Viking¿ 300 Lift  Model 2040003 (S/N 800 001 - 804 999)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1818-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1818-2015Class IITerminatedVoluntary: Firm initiated