Device recall: TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment…
Class II FDA enforcement event 72273. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work properly due to fluid intrusion within the control switches and/or the control board assembly.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Berchtold Corp. started this device recall on 23 Sep 2015. The firm address in the FDA record is in Charleston, SC. FDA put the recall in Class II. FDA event 72273 has 1 product record. The first FDA enforcement report date is 28 Oct 2015. The record gives the status Terminated, with the termination date 17 Nov 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US (nationwide), Canada, and Germany
Recalling firm
Berchtold Corp., Charleston, SC.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0154-2016 | TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in… | 2129 units | Class II | Terminated | 28 Oct 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Apr 2016 | Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may | Device | Class II | 1 |
| 12 Mar 2013 | Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables | Device | Class II | 1 |
| 10 Jul 2012 | Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures. | Device | Class III | 1 |
| 16 Apr 2012 | OPERON D850 Surgical Table Product Usage: Surgical Table | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0154-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 72273. https://recallregister.com/fda/ii/72273/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US (nationwide), Canada, and Germany
- What quantity of product is in FDA event 72273?
- The FDA record gives this quantity:
2129 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.