Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1818-2015 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
