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Terminated

2000 Vascular with 30 Degree option

FDA Recall Z-0353-2020 · Posted None

Recalling FirmHeritage Medical Products, Inc.
Recall StatusTerminated
Product CodeLGX
Date Initiated2016-09-02
Date Terminated2020-12-14
Product Quantity167 beds (159 US, 8 OUS)

Reason for Recall

Potential for bed to drop suddenly at the head while a patient is laying on it.

Firm Action

Heritage Medical Products, Inc. notified customers on about 09/02/2016 via "Advisory Notice." Customers were informed that Heritage Medical has designed a reinforcement kit as a correction, which will be supplied to customers. Customers were instructed to contact Heritage Medical, provide the serial number of their bed to ensure it is affected, and Heritage Medical will provide a free kit that will reinforce the area on the affected devices that has experienced failures. The contact information is a follows: Heritage Medical Products, Inc., ATTN.: Trunnion Reinforcement Kit, 10380 CR 6310, West Plains, MO 65775, (888) 256-8748.

Root Cause

Device Design

Distribution Pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, OH, OK, OR, PA, SC, TX, UT, VA, WI, WY, PR. International distribution to Canada, Saudi Arabia, Trinidad & Tobago.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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